Request for amendments to the Regulations on the Supervision and Administration of Medical Devices

On October 1, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Drugs and Medical Devices (hereinafter referred to as "Innovative Opinions"), and put forward 36 important In order to ensure that the relevant reform measures are in evidence, the General Administration of Food and Drug Administration has carefully studied the contents of the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the "Regulations"), and at the same time, the effective supervision of medical devices And to clarify the provisions of the "Regulations" in conflict with the "Innovation Opinions" reform measures, to supplement and improve the regulatory basis for reform measures to fill the loopholes in regulation and provide strong legal support for reform and supervision practice, Form a "medical device supervision and management regulations amendments (draft draft)", is now open to the public for comments. Please all sectors of the community closely around the "Innovation Opinions" proposed reform measures, comments and suggestions, please comments and suggestions The form of e-mail was fed to the Legal Department of Food and Drug Administration before November 12, 2017 And please specify the 'Medical Device Supervision and Management Regulations Amendment'.

Contact E-mail: xuxy@cfda.gov.cn

Annex: 1. "Medical Device Supervision and Management Ordinance," the amendment (draft draft) the relevant circumstances of the note

2. "Medical Device Supervision and Management Regulations" amendment (draft draft)

3. "Medical Device Supervision and Management Regulations" amendment (draft for draft) hooded manuscripts

General Office of Food and Drug Administration

October 31, 2017

On October 1, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Drugs and Medical Devices (hereinafter referred to as the "Innovative Opinions") and put forward 36 important reform measures. Measures to implement the law, the Food and Drug Administration on the urgent need to modify the "medical device supervision and management regulations," the contents of the study carefully, the formation of "medical device supervision and management regulations amendments (draft draft)", the relevant situation as follows:

The Regulations were revised in 2014 and were revised in May 2017. The changes were closely focused on ensuring that the reform proposals of the "Innovative Opinions" were implemented as soon as possible, and that the "Regulations" should not be frequent To revise the outstanding issues that effectively regulate the effective supervision of medical devices, and to revise the provisions of the Regulations that are in conflict with the "Innovative Opinions" reform measures, supplement and improve the regulatory basis for reform measures, fill the regulatory loopholes, Regulatory practice provides strong legal support.

Draft draft for the existing "Regulations" increased by 8, modify 19. The main amendments include:

(1) to improve the licensing system for medical devices listed in the second chapter 'medical device product registration and filing' in the provisions of the provisions of the registrant and filing conditions and the specific obligations should be fulfilled (Article IX); Person or filing person can own production and operation can also be commissioned by other enterprises to produce their products (Article 11.) in the post-marketing regulatory links, a clear registration and filing of the adverse event monitoring, re-evaluation and defective product recall the main responsibility (Article 51, Article 55, Article 56). In the legal liability, improve the relevant penalties (Article 71, Article 73, Article 74). Foreign registrants and filmmakers in the territory proxy (Article 10), and the establishment of the corresponding legal liability clause (Article 75) of the provisions of the people 's management regulations, clear the agent should have the conditions and obligations to be fulfilled, requiring agents to the Provincial Food and Drug Administration for the record (Article 10).

(2) to reform the clinical trial management system.Third category of high-risk products clinical trial approval by the express permission to implied license (Article 22); increase the clinical data to accept clinical trials, clinical trials medical instruments (Article 20, Article 23). Summarize the experience of supervision and make clear management requirements for clinical evaluation (Article 20).

(3) to optimize the approval process.New domestic and foreign unlisted innovative medical equipment, no longer require the provision of overseas listing sales certificate (Article 14, paragraph 2.) for the second category, the third category of medical equipment to apply for registration Product inspection report, should be issued by the medical device inspection agency inspection report, adjusted to be the applicant's self-test report, it can be a qualified medical device inspection agency issued a test report (Article XIV paragraph 3) (Article 16). Provided that the problems found in the treatment of rare diseases, serious life-threatening and no effective treatment of disease, emergency response to public health emergencies and other medical devices (Article 16.) Continue to register to improve, clearly defined, not required to carry out adverse event monitoring or post-marketing research, re-evaluation, can not guarantee product safety and effective, not to continue registration (Article 18)

(4) to improve the regulatory requirements after the listing of the regulatory practice on the basis of a serious summary, to further improve the product after the listing of regulatory requirements.

First, improve the management of the second category of medical equipment. Implementation of the 'discharge service package' requirements, part of the circulation process through the regular management to ensure its safety, effectiveness of the second category of medical equipment, exemption from the record requirements Thirty-four).

Second, to strengthen the supervision of the old medical equipment to further strengthen the supervision of the old medical equipment, explicitly prohibit the use of medical equipment has been used (Article 44, Article 71).

Third, improve the re-examination system.To further standardize the re-examination behavior, the re-examination system has been perfected, the parties to the test results have objections, it should be in the State Council food and drug supervision and management departments published in the list of re-inspection agencies to select inspection agencies (Article 62).

(5) to strengthen the supervision of the construction team clearly stipulates that the state to establish a medical device professional inspector system, above the county level food and drug regulatory authorities set up specialized agencies, with specialized personnel to undertake medical equipment inspection work. Higher food and drug regulatory authorities can deploy the use of lower food Drug regulatory authorities of the inspectors; food and drug supervision and management departments of the inspectors to implement classification management, and the establishment of assessment, compensation, promotion and other incentive and restraint mechanisms (Article 57).

(6) to the punishment of the implementation of the central instructions on the spirit of the additional penalties to the specific terms of the provisions of the medical device registrant, filing, production and operation enterprise , The use of units deliberately the implementation of illegal acts or the existence of gross negligence, or serious violations of the circumstances, the nature of bad or cause serious consequences and other serious adverse social impact of its legal representative, the main person in charge, directly responsible for the competent personnel and other direct The responsible person shall be fined not less than 30% but not more than one time of the previous year's income (Article 79).

The next step, the Food and Drug Administration will speed up the "Medical Device Supervision and Management Ordinance" to amend the work process, carefully study the views of the proposed advice, further revised and improved, and strive to early draft amendments to the State Council Legislative Affairs Office.

Annex 2

In order to deepen the reform of the examination and approval system, encourage the innovation of medical devices and solve the urgent problems to be solved in the practice of supervision, the Regulations on Supervision and Administration of Medical Devices are as follows:

First, add one, as Article IX: 'medical device registrants or filmmakers in their own name to the market, should have the appropriate quality management, risk prevention and control, continuous research, accountability and other capabilities to ensure that the submitted study Data and clinical trial data is true, complete, traceable, the full life cycle of medical equipment to bear legal responsibility.

The medical device registrant or filer shall fulfill the following obligations:

(1) to establish a quality management system compatible with the product and maintain the effective operation of the quality management system on a regular basis to self-examination and to the food and drug supervision and management departments to submit self-examination report;

(B) to establish a post-IPO continuing research and risk control plan and ensure its effective implementation;

(3) to carry out adverse event monitoring and reassessment work according to law;

(D) the establishment of product traceability and recall system and maintain effective operation;

(5) Other obligations stipulated by the State Council for Food and Drug Administration.

Second, add one, as Article X: 'medical device registrants or filmmakers in the country, should be set up in China by the representative office or designated in China have the appropriate quality management, risk prevention and control, the ability to compensate the ability of enterprises Legal person as agent.

The agent of an overseas medical device or the agent of the filing person shall perform the following obligations:

(1) to handle the registration or filing of medical devices in accordance with the provisions of these Regulations and to liaise between the food and drug supervision and administration department and the registrant or filing person of overseas medical devices;

(2) promptly communicate the relevant laws and regulations and technical requirements to the registrant or filing person of the overseas medical device and supervise the implementation;

(3) To undertake the monitoring of the adverse events of imported medical equipment under domestic sales and report to the food and drug supervision and administration departments on the adverse events of medical devices that are imported outside the medical equipment;

(4) to coordinate the recall of medical products after the listing of medical products, and report to the food and drug supervision and management departments;

(5) to assist the food and drug supervision and administration departments to carry out inspection and illegal investigation of the registered persons or filing persons of overseas medical devices;

(6) the product quality and related services violations, and overseas medical device registrants or filers jointly assume legal responsibility.

The agent of the overseas medical device or the agent of the filing person shall record the relevant agency information to the food and drug supervision and administration department of the people 's government of the province, autonomous region or municipality directly under the Central Government.

Third, add one, as Article XI: 'medical device registrant or filing person can produce or sell their own medical equipment, can also be commissioned in accordance with the provisions of this Ordinance, with the appropriate conditions of medical equipment production and operation of enterprises to produce or sell medical equipment. Where a medical device registrant entrusts others to produce or sell it, it shall enter into a contract with the production and operation enterprise of the entrusted medical device to clarify the rights, obligations and responsibilities of both parties so as to ensure that the production and operation of the entrusted enterprise conforms to the requirements prescribed in these Regulations.

'By the medical device registrants or filmmakers commissioned to carry out research and development, clinical trials, production and operation of enterprises, institutions and individuals, bear the provisions of laws and regulations and agreements agreed.

4. Article 10 shall be changed to Article 13 and the second paragraph shall be amended as follows: 'The overseas filing of the first category of medical equipment exported to China shall be supervised by the agent of the State Council in the territory of the People's Republic of China Management department to submit the record and the filing of the country (region) competent authorities to permit the listing of medical equipment sales documents.

5. Article 11 shall be changed to Article 14 and the second paragraph shall be amended to read as follows: 'The applicant for the registration of the second category and the third category of medical equipment in China shall, by its agent in China The applicant shall submit the application for registration of the application documents and the supporting documents of the country where the applicant is located in the country where the applicant is located in the country where the applicant is located. The innovative medical device not listed on the inside and outside of the medical device may not be submitted to the applicant The competent authorities of the country (region) shall permit the medical equipment to be listed for sale.

The third paragraph is amended as follows: 'The second category, the third category of medical device product registration application information in the product inspection report can be registered applicant' s self - test report or commissioned by a qualified medical device inspection agency issued a test report.

Sixth, the twelfth to Article 16, add a paragraph as paragraph 2: 'for the treatment of rare diseases, serious life-threatening and there is no effective treatment of disease and emergency response to public health emergencies such as medical Equipment, food and drug supervision and management departments may be accompanied by conditions for registration, and in the medical device registration certificate in the relevant matters.

7. Article 15 shall be changed to Article 18 and the third paragraph of paragraph 3 shall be amended to read as follows: 'Where the registrant fails to complete the medical device registration certificate within the prescribed time limit;'

Add one item as the fourth item: 'fail to collect product safety information through adverse event monitoring, or do not carry out post - market research, re - evaluation, and can not guarantee product safety and efficiency.

8. Article 17 should be changed to Article 20, and the first paragraph is amended as: 'medical equipment should carry out clinical evaluation, through clinical literature, clinical experience data, clinical trials and other information on the product to meet the requirements or use The scope of application to confirm the first category of medical equipment products for the record, no need for clinical trials.Application of the second category, the third category of medical device product registration, one of the following circumstances, can be exempt from clinical trials:

Add a paragraph, as the third paragraph: 'clinical data obtained outside the country, in line with China' s medical equipment registration requirements, can be used in China to apply for registration.

9. Article 19 shall be changed to Article 22 and the first paragraph shall be amended as follows: 'Where the clinical test of the third type of medical device has a high risk to the human body, it shall be approved by the food and drug supervision and administration department under the State Council. The State Council Food and Drug Administration shall, within sixty working days from the date of accepting the application for the corresponding clinical trial, decide whether or not to agree to carry out the clinical trial; if the decision has not been made within the time limit, the applicant may carry out the clinical trial. The third category of medical devices in risk shall be formulated, adjusted and promulgated by the Food and Drug Administration of the State Council.

10, the addition of a, as the twenty-third: 'ongoing clinical trials for the treatment of serious life-threatening and no effective treatment of diseases of medical equipment, the initial observation may benefit, and meet the ethical requirements, Agreed that it can be used in other patients in a clinical trial facility and that safety data can be used for registration applications.

11. Article 24 shall be changed to Article 28 and revised as: 'Medical equipment sold in China shall be produced in accordance with the requirements of the quality control standard for the production of medical devices. People, production enterprises should be in accordance with the requirements of medical equipment production quality management standards, establish and improve the production of medical equipment and adapt to the quality management system and ensure its effective operation; in strict accordance with the registered or filed product technical requirements of production, to ensure that the factory Medical devices comply with mandatory standards and technical requirements for registered or filed products.

The manufacturer shall submit the self-examination report to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government, and the imported medical device shall, through the inspection and operation of the quality control system, The agent shall report to the food and drug supervision and administration department of the people 's government of the province, autonomous region or municipality directly under the Central Government where the agent is located.

12, the twenty-fifth to twenty-ninth, and amended as: 'medical equipment production conditions change, no longer meet the medical device quality management system requirements, medical device registrant or filer, production Enterprises should immediately take corrective measures; may affect the safety and effective medical equipment, should immediately stop the production activities, and to the local people's government food and drug supervision and management departments to report; import medical equipment should be through its agent to the agent where the province, Autonomous regions and municipalities directly under the Central Government and food and drug supervision and management departments report.

Article 13 shall be changed to Article 34 and shall be added as a second paragraph: 'Where is the second type of medical device operated in the course of circulation through routine management to ensure its safety and effectiveness, No need for record. No need to apply for the record of the second category of medical equipment product list by the State Council food and drug supervision and management departments to develop.

Article 14 shall be changed to Article 44 and be amended as follows: 'The medical device business enterprise shall not engage in non - legally registered, non - qualified documents and expired, expired, eliminated, and used medical equipment.'

15, the forty-first article will be changed to Article 45, and add a paragraph as the first paragraph: 'medical device use units shall not use the law without registration, no qualified documents and expired, expired, out of medical equipment . '

16. Replace article 47 with Article 51 and add a paragraph as the first paragraph: 'The medical device registrant and the filing person shall be provided with an adverse event monitoring agency and personnel who are compatible with their products and their size. Its products take the initiative to carry out adverse event monitoring; found that adverse medical devices or suspicious medical equipment adverse events, should be in accordance with the State Council food and drug supervision and management departments to the medical device adverse event monitoring technology institutions to report and timely investigation and evaluation, report evaluation As a result, take the initiative to control the product risk.

The original paragraph as the first paragraph, and amended as: 'medical equipment production and operation of enterprises, the use of units should be the production or use of medical equipment to carry out adverse event monitoring; found adverse medical devices or suspicious adverse events, should be timely Feedback medical device registrant or filing person, and in accordance with the provisions of the State Council food and drug supervision and management departments, to the medical device adverse event monitoring technology institutions report.

Seventeen, the fifty to four, and amended as: 'medical device registrant, filing, production and operation of enterprises, the use of units should be medical device adverse event monitoring technology institutions, food and drug supervision and management To carry out the investigation of adverse events in medical devices.

Article 18 shall be changed to Article 55 and the first paragraph shall be amended to read as follows: 'Where the medical device registrant or the filing person shall take the initiative to carry out the reassessment of the listed medical device in any of the following circumstances:

(A) according to the development of scientific research, the safety of medical devices, effective understanding of the change;

(B) medical device adverse event monitoring, the assessment results show that medical devices may be defective;

(3) other circumstances stipulated by the food and drug supervision and administration departments under the State Council that need to be reevaluated.

If the medical device registrant or the filing person fails to perform the medical equipment re-evaluation obligation as prescribed, the food and drug supervision and administration department at or above the provincial level shall order the medical device registrant or the filing person to carry out re-evaluation. , The provincial and above food and drug supervision and management departments can directly organize the re-evaluation of medical equipment.

The original paragraph 2 as the third paragraph, and amended as: 'medical device registrant or filing should be based on the re-evaluation results, the listed medical devices have been continuous improvement, according to the provisions of the registration changes or record changes. That the registered medical equipment can not be safe and effective, The original issuing department shall cancel the medical device registration certificate or cancel the record and publish it to the public.It is not allowed to produce, import, operate and use the medical device that has been canceled or registered medical equipment.

Nineteen, the fifty-second article to Article 56, and amended as: 'medical device registrants or filmmakers found that their production of medical equipment does not meet the mandatory standards, registered or filed product technical requirements or There are other defects, should immediately stop production, notify the relevant production and operation enterprises, the use of units and consumers to stop production and operation and use, recall the market has been sold medical equipment, to take remedial, destruction and other measures to record the relevant information, And the medical device recall and processing to the food and drug supervision and management departments and health departments in charge of the report.

If the production and operation of medical equipment is found to be in the production and operation of medical devices, the production and operation shall be stopped immediately, and the relevant production and operation enterprises, the units and consumers shall be notified and the operation and notification shall be recorded. That should belong to the provisions of the preceding paragraph need to recall the medical equipment, should be immediately recalled.

Where a medical device registrant or a filing person or a production and operation enterprise fails to implement the recall or ceases to operate in accordance with the provisions of this Article, the food and drug supervision and administration department may order it to recall or stop the operation.

Twenty, add one, as Article 57: 'national establishment of medical equipment professional inspector system. People's Government above the county level food and drug supervision and management departments set up specialized agencies, with specialized personnel, commitment to medical equipment inspection work. The government food and drug supervision and administration departments may deploy the inspectors of the food and drug supervision and administration departments of the people's governments at lower levels.

'Food and drug supervision and management departments of the inspectors to implement classification management, and the establishment of assessment, compensation, promotion and other incentive and restraint mechanisms.

(1) whether the medical device registrant, the filing person and the manufacturing enterprise are in accordance with the technical requirements of the registered or filed product, and shall, in accordance with the provisions of Article 58, Organization of production;

(2) whether the quality management system of the medical device registrant, the filing person and the production enterprise is maintained in an effective manner;

(3) whether the conditions of production and operation of medical device registrants, filing persons and production and operation enterprises continue to meet the statutory requirements.

Article 22 shall be changed to Article 62 and the third paragraph shall be amended to read as follows: 'Where the parties have objection to the results of the inspection of the medical device inspection institution, it may, from the date of receipt of the inspection result 7 Within one working day to the State Council food and drug supervision and management departments published in the list of re-inspection agencies in the medical device inspection agency to submit a re-examination application.Application of the applicant did not submit a re-examination of the test results. The equipment inspection agency shall make a review conclusion within the time stipulated by the food and drug supervision and administration department under the State Council, and the conclusion of the examination shall be the final inspection conclusion.

(2) the registrant or filing person of a medical device, the manufacturer shall not, in accordance with the registered or filed case, Product technical requirements of the organization of production, or not in accordance with the provisions of this Ordinance to establish a quality management system and maintain effective operation;

(3) to operate, to use non-qualified documents, expired, expired, eliminated, used medical devices, or the use of medical devices not registered in accordance with the law;

Increase the amount as a second paragraph: 'the import of medical equipment, its production in violation of the relevant provisions of Article 28 of these regulations, according to the law to make interviews, deadline for rectification, issued a letter of command, suspended imports, supervision of recall products, Use, do not continue to register and so on; the circumstances are serious, you can revoke its medical device registration certificate or cancel the record certificate.

Twenty-four, the sixty-eight to Article 73, and the first amendment to: '(a) medical device registrant or filing, production enterprises did not submit the required quality management system self-examination report of; '

(10) medical device registrant or filing person, production and operation of enterprises, the use of units in accordance with the provisions of this Ordinance to carry out medical device adverse event monitoring, did not report adverse events in accordance with the requirements, or adverse events on the medical device Monitoring technical institutions, food and drug supervision and management departments to carry out the investigation of adverse events do not cooperate.

25, add one as Article 74: 'Medical device registrants or fillers who fail to carry out the re-evaluation of medical devices in accordance with the provisions of these Regulations and hide the re-evaluation results shall file an application for write-off without making any provision for food and drug Where the re-evaluation of medical devices organized by the supervisory and administrative department fails to cooperate, the food and drug administration department of the people's government at or above the county level in the place where the supervision and administration department conducts the reorganization shall order it to make corrections and give a warning; if it refuses to make corrections, it shall be fined not less than 5,000 yuan but not more than 20,000 yuan, The registration or filing department shall make a decision of canceling the certificate of registration of medical device or canceling the record, and make a timely announcement to the public.

Article 25: "Where an imported medical device agent fails to perform its duties in accordance with the provisions of these Regulations, a food and drug administration at or above the county level shall give a warning and order it to make corrections and may concurrently place 50,000 If the circumstances are serious, the institution and the relevant responsible person shall not engage in activities related to the import of medical equipment agents within 5 years.

27th, add one as Article 79: 'Medical device registrants, fillers, production and operation enterprises and employers who violate the provisions of this Law by one of the following circumstances shall be punished in accordance with the aforesaid provisions of this Chapter It may also impose a fine of not less than 30% but not more than 1 times the legal representative, principal person in charge, direct person in charge, and other directly responsible personnel on the legal representative, principal responsible person, and other directly responsible personnel:

(A) intentionally committing an illegal act or there is a gross negligence;

(2) The illegal act is in serious circumstances and of a poor nature;

'(3) If the illegal act causes serious consequences or other serious adverse social impacts.'

This amendment shall come into force on the day it is announced.

The Regulation on the Supervision and Administration of Medical Devices shall be revised accordingly and re-announced according to this decision.

Article 1 These Regulations are formulated in order to ensure the safety and effectiveness of medical devices and to protect the health and safety of human beings.

Article 2 The development, production, operation and use of medical devices and their supervision and administration within the territory of the People's Republic of China shall be subject to these Regulations.

Article 3 Food of the State Council drug The department in charge of supervision and administration shall be responsible for the supervision and administration of medical devices throughout the country and the relevant departments under the State Council shall be responsible for the supervision and administration of medical devices within their respective responsibilities.

The food and drug supervision and administration department of the local people's government at or above the county level shall be responsible for the supervision and administration of the medical devices in its own administrative area and the relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective responsibilities.

The food and drug administration under the State Council shall, in conjunction with the relevant departments under the State Council, implement the plans and policies for the state's medical device industry.

Article 4 The State shall classify the medical devices according to the degree of risk.

The first category is a low degree of risk, the implementation of routine management can guarantee its safe and effective medical equipment.

The second category is a moderate risk, need strict control management to ensure its safe and effective medical equipment.

The third category is a high-risk, need to take special measures to strictly control management in order to ensure its safe and effective medical equipment.

Evaluation of the degree of risk of medical devices, medical devices should be expected to consider the purpose, structural characteristics, methods of use and other factors.

The Food and Drug Administration of the State Council shall be responsible for formulating the classification rules and classification catalog of medical devices, and analyzing and evaluating the risks of medical devices in a timely manner according to the production, operation and use of the medical devices, and making adjustments to the catalogs. Directory, it shall fully listen to the opinions of the medical device manufacturing enterprises as well as the employing units and trade organizations, and refer to the practice of international classification of medical devices. The catalog of medical devices shall be announced to the public.

Article 5 The development of medical devices should follow the principles of safety, efficiency and conservation.The state encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the popularization and application of new medical devices and promotes the development of medical device industry.

Article 6 Medical device products shall conform to the compulsory national standards for medical devices; if there is no mandatory national standard, they shall conform to the compulsory industry standard of medical equipment.

The list of medical devices used by the State Council shall be formulated, adjusted and promulgated by the department of food and drug supervision and administration of the State Council in conjunction with the department in charge of hygiene and family planning of the State Council, which can ensure safe and effective medical equipment and do not include a list of medical devices for one-time use. Design, production process, disinfection and sterilization technology to improve the use of re-use can ensure a safe and effective medical equipment, should be adjusted to a one-time use of medical equipment directory.

Article 7 The medical device industry organization shall strengthen the industry self-discipline, promote the construction of the credit system, urge enterprises to carry out production and business activities according to law, and guide enterprises to be honest and trustworthy.

Article VIII of the first category of medical equipment for product record management, the second category, the third category of medical equipment to implement product registration management.

Article 9 The registrant or filing person of a medical device shall bring the product to the market in its own name and shall have the corresponding ability of quality management, risk prevention and control, continuous research and liability compensation to ensure that the submitted research data and clinical trial data are true and complete , Can be traced back to the full life cycle of medical equipment to bear legal responsibility.

The medical device registrant or filing person shall fulfill the following obligations:

(1) to establish a quality management system compatible with the product and maintain effective operation, self-examination of the operation of the quality management system on a regular basis and submit to the food and drug supervision and management departments self-examination report;

(B) to establish a post-IPO continuing research and risk control plan and ensure its effective implementation;

(3) to carry out adverse event monitoring and reassessment work according to law;

(D) the establishment of product traceability and recall system and maintain effective operation;

(5) other obligations stipulated by the food and drug supervision and administration department under the State Council.

Article 10 Where a medical device registrant or a filing person is outside the territory, it shall be an agent of an enterprise established by a representative office established in China or designated as the corresponding quality management, risk prevention and control and liability compensation in China.

The registrant of an overseas medical device or the agent of the filing person shall perform the following obligations:

(1) to handle the registration or filing of a medical device in accordance with the provisions of these Regulations and to liaise with the registrant of the food and drug administration and the registrant or filing person of the overseas medical device;

(2) promptly communicate the relevant laws and regulations and technical requirements to the registrant or filing person of the overseas medical device and supervise the implementation;

(3) to undertake the monitoring of the adverse events of imported medical devices under domestic sales and report to the food and drug supervision and administration departments on the adverse events of medical devices occurring outside the imported medical devices;

(4) to coordinate the recall of medical products after listing the medical products, and report to the food and drug supervision and management departments;

(5) to assist food and drug supervision and administration departments to carry out inspection and illegal investigation of the registered persons or filing persons of overseas medical devices;

(6) the product quality and related services violations, and foreign medical device registrants or filers jointly assume legal responsibility.

The agent of the overseas medical device or the agent of the filing person shall record the relevant agency information to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Article 11 A medical device registrant or a filing person may produce or sell medical equipment on his own or may, in accordance with the provisions of these Regulations, produce or sell medical equipment with the corresponding medical equipment production and operation business. The medical device registrant entrusts others to produce or Sales, should be entrusted with the production and operation of medical equipment signed a contract to clear the rights, obligations and responsibilities to ensure that the production and operation of enterprises entrusted with the provisions of the provisions of this Ordinance.

The enterprises, institutions and individuals entrusted by R & D, clinical trial, production and operation of the medical device registrant or filing person shall bear the responsibility stipulated in the laws and regulations and the agreement.

Article 12 The first category of medical device products for the record and apply for the second category, the third category of medical device product registration, the following information should be submitted:

(A) product risk analysis information;

(2) product technical requirements;

(3) product inspection report;

(D) clinical evaluation data;

(5) product brochures and label samples;

(6) documents related to product development and production related to quality management system;

(7) other information necessary to prove the safety and effectiveness of the product.

Medical device registration applicant, filer should be responsible for the authenticity of the submitted information.

Article 13 The first category of medical device products for the record, by the filing to the local district of the municipal people's government food and drug supervision and management departments to submit filing information, which can be a product inspection report self-test report; clinical evaluation data Does not include clinical trial reports, can be obtained through the literature, similar products obtained from the clinical use of the data to prove that the medical device safe and effective information.

To the territory of China's exports of the first category of medical equipment for the production of foreign enterprises filing by its representative offices in China or the designated domestic enterprises in China as agents, to the State Council food and drug supervision and management departments to submit filing materials and filing The competent authority of the host country (region) shall permit the listing of the medical device to be sold.

Where the matters specified in the record material have changed, the record shall be changed to the original filing department.

Article 14 Application for registration of a second type of medical device product shall be submitted to the food and drug supervision and administration department of the local people's government of the province, autonomous region or municipality directly under the Central Government where the application for registration of the application for registration of the third category of medical device products, The State Council Food and Drug Administration shall submit the application materials for registration.

An applicant for registration of an offshore manufacturing enterprise that exports Type 2 and Type 3 medical devices to our country shall, from its representative office established in the territory of our country or as an agent of an enterprise legal person designated in the territory of China, apply to the State Food and Drug Supervision and Administration Department Submit the application materials for registration and the supporting documents of the competent authority of the country (or region) where the applicant is registered to permit the medical device to be marketed or sold The innovative medical device not listed in the PRC and the overseas may not be submitted to the competent authority of the country (region) of the applicant for the registration Instruments listed on the sale of documents.

The second and third types of medical device product registration application information in the product inspection report should be the medical device inspection agency issued a test report may be a registered applicant's self-test report or commissioned by a qualified medical device inspection agency issued a test report Clinical evaluation information should include clinical trial reports, except for medical devices exempt from conducting clinical trials in accordance with the provisions of Article 17 of these Regulations

Article 15 The department of food and drug administration that accepts the application for registration shall, within 3 working days from the date of accepting the application, refer the application for registration information to the technical review agency, which shall, after completing the technical review and review, submit to the competent authority for food and drug supervision and administration Department submits review comments.

Article 16 The department in charge of food and drug administration that accepts the application for registration shall make a decision within 20 working days from the date of receiving the review opinions, and for those who meet the safety and effective requirements, be allowed to register and issue a medical device registration card; Meet the requirements, not to register and explain the reasons in writing.

For the treatment of rare diseases, serious life-threatening and there is no effective means of treatment of diseases and emergency medical emergencies such as the urgent need to approve, food and drug administrations may be subject to conditions approved registration, and medical device registration certificate set forth in the relevant matter.

When organizing a review of the technical review of imported medical devices that the State Food and Drug Administration considers necessary for the verification of the quality management system, a quality management system inspection organization shall be organized to carry out quality management system verification.

Article 17 Registered Class II and Class III medical device products, such as the design, raw materials, production process, scope of application, the use of methods such as the occurrence of substantial changes, may affect the medical equipment safe and effective, the registrant It shall apply to the original registration department for change of registration formalities; the occurrence of non-material changes, does not affect the safety and effective medical equipment, should change the situation to the original registration department for the record.

Article 18 The medical device registration certificate shall be valid for 5 years, and if it is necessary to extend the registration period, it shall submit an application for renewal of registration to the original registration department within 6 months after the expiration of the validity period.

In addition to the provisions of paragraph 3 of this Article, the food and drug supervision and administration department that has received the application for renewal of registration shall make a decision on granting the approval before the expiry of the validity period of the medical device registration certificate.

In any of the following circumstances, do not continue to register:

(1) Where the registrant fails to file an application for continuation within the prescribed time limit;

(2) The compulsory standard for medical devices has been revised and the medical equipment for renewal of application can not meet the new requirements;

(3) For medical devices that are urgently needed for the treatment of rare diseases and in response to public health emergencies, the medical device registration certificate has not been completed within the prescribed time limit. Where the conditions are approved, the registrant is not within the prescribed time limit Within the medical device registration certificate to complete the matter;

(4) failing to collect product safety information through the monitoring of adverse events or failing to carry out post-market research and re-evaluation as required, and can not guarantee the safety and efficiency of the products.

Article 19 For newly developed medical devices that have not yet been included in the catalog, the applicant may apply for registration of products directly in accordance with the provisions of this Regulation concerning the registration of the third category of medical device products, and may also judge the product categories according to the classification rules and apply to the State Council The drug regulatory authority shall apply for registration or carry out product filing in accordance with the provisions of these Regulations after the application for confirmation of the category.

The food and drug supervision and administration department of the State Council shall determine the categories according to the degree of risk, and the medical devices that are registered for registration shall be included in the catalog in time. If the application is confirmed, the food and drug supervision and administration department under the State Council shall, Within 20 working days from the date of the medical device to determine the type and inform the applicant.

Article 20 Medical devices should carry out clinical evaluation, through the clinical literature, clinical experience data, clinical trials and other information on whether the product to meet the requirements or the scope of application to confirm the first type of medical device products for the record, no need for clinical trials. Application of the second category, the third category of medical device product registration, should be clinical trials; However, one of the following circumstances, can be exempt from clinical trials:

(A) the working mechanism is clear, the design stereotypes, the production process is mature, has been listed with the same variety of medical devices for many years and no serious adverse event records, do not change the routine use;

(B) through the non-clinical evaluation to prove that the medical device safe and effective;

(C) through the same kind of medical equipment clinical trials or clinical use of the data obtained by the analysis and evaluation, to prove that the medical device safe and effective.

The list of medical devices exempted from clinical trials shall be formulated, adjusted and promulgated by the Food and Drug Administration of the State Council.

Foreign clinical data obtained in accordance with China's medical device registration requirements, can be used in China to apply for registration.

Article 21 The clinical trials of medical devices shall be carried out in accordance with the requirements of the quality control standard of clinical trials of medical devices and shall be carried out in clinical trial institutions with corresponding conditions and shall be supervised by the people's government of the provinces, autonomous regions and municipalities directly under the Central Government where the clinical trials are located The competent department of food and drug administration for clinical trials shall inform the competent department of food and drug supervision and the department of health care at the same level of the place where the clinical trial institution is located.

The medical device clinical trial institution shall implement the record management.The condition and record management methods of medical device clinical trial institutions and the quality management standards of clinical trial shall be formulated and promulgated by the food and drug regulatory department under the State Council in conjunction with the competent department of health and family planning of the State Council.

Article 22 The clinical trials of the third type of medical devices that pose a high risk to the human body shall be subject to the approval of the food and drug administration department under the State Council. The department of food and drug administration under the State Council shall, from the date of accepting the application for the corresponding clinical trial, Within the working day to decide whether to agree to carry out clinical trials; overdue decisions, registered applicants can carry out clinical trials.Clinical trials on human body has a higher risk of the third category of medical equipment catalog by the State Council Food and Drug Administration to develop, adjust and Announced.

The State Council department in charge of food and drug administration approval of clinical trials should be carried out on the equipment to be undertaken clinical trials of medical devices, professionals and other conditions, the degree of risk of the medical device, clinical trial implementation plan, clinical benefit and risk comparative analysis report Analysis .Approval of clinical trials, it should be informed of the clinical trial sponsor and the clinical trial institutions located in provinces, autonomous regions and municipalities directly under the Central People's Government food and drug supervision and management departments and health planning department.

Article 23 For medical devices undergoing clinical trials for the treatment of diseases that are seriously life-threatening and have no effective treatment, the initial observations may benefit and comply with ethical requirements and are subject to informed consent before conducting clinical trials For other patients within the organization, their safety data can be used for registration applications.

Article 24 The medical device manufacturing activities shall meet the following conditions:

(1) There are production sites, environmental conditions, production equipment and professional and technical personnel that are suitable for the production of medical devices;

(B) a body or full-time inspection staff and inspection equipment for the quality inspection of the medical devices produced;

(3) to ensure the quality of medical equipment management system;

(D) have the ability to adapt to the production of medical equipment after-sales service;

(5) product development, production process documentation requirements.

Article 25 Whoever engages in the production of medical devices of the first category shall be filed with the food and drug supervision and administration department of the municipal people 's government at the local level and set up by the production enterprise and submit its supporting documents in accordance with the conditions stipulated in Article 20 of these Regulations.

Article 26 The production enterprise shall apply to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government for production license and submit it to meet the conditions stipulated in Article 20 of these Regulations. Of the proof of information and the production of medical equipment registration card.

The food and drug supervision and administration department that accepts the application for production license shall, within 30 working days from the date of acceptance, examine the application materials and carry out verification according to the requirements of the quality control regulations for the production of medical devices formulated by the food and drug supervision and administration department under the State Council. Conditional, granted permission and issued to the medical device production license; do not meet the requirements of the conditions, without permission and a written explanation of the reasons.

The medical device production license is valid for 5 years, and if the expiry date is required, the continuation procedure shall be followed according to the relevant laws and regulations of the administrative license.

Article 27 The quality control rules for the production of medical devices shall clearly stipulate the safety and effective matters affecting the design and development of medical devices, the conditions for the production equipment, the procurement of raw materials, the control of the production process, the establishment of the enterprises and the staffing and so on.

Article 28 Medical equipment sold in China shall conform to the requirements of the quality control standard for the production of medical devices, and the medical device registrant or filing person and manufacturer shall establish and improve the quality of medical equipment according to the requirements of the quality control of medical equipment production And the production of medical equipment to adapt to the quality management system and to ensure its effective operation; in strict accordance with the registered or filed product technical requirements of production, to ensure that the factory's medical equipment to meet the mandatory standards and registered or filed product technical requirements.

Medical equipment registrant or filing person, the production enterprise shall conduct self-examination on the operation of the quality management system on a regular basis and submit the self-examination report to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government; The agent shall report to the food and drug supervision and administration department of the people 's government of the province, autonomous region or municipality directly under the Central Government where the agent is located.

Article 29 Where the production conditions of a medical device manufacturer change and no longer meet the requirements of the medical device quality management system, the manufacturer or the filing person of the medical device shall immediately take the rectification measures; it may affect the safety and effective operation of the medical device. The import of medical equipment shall be reported through the agent to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the agent is located, and shall report to the food and drug supervision and administration department of the people's government at the local level.

Article 30 Medical devices shall use the common name, and the generic name shall conform to the naming rules for medical devices formulated by the food and drug supervision and administration department under the State Council.

Article 31 Medical devices shall have the contents of the instructions, labels, brochures and labels, which shall be consistent with the relevant contents of the registration or filing.

Medical device instructions, labels should indicate the following:

(A) common name, model, specifications;

(2) the name and address of the production enterprise, the production address and the contact information;

(3) the number of the technical requirements of the product;

(D) date of production and period of use or expiry date;

(5) product performance, the main structure, the scope of application;

(6) contraindications, precautions and other contents that require warnings or reminders;

(7) installation and use instructions or illustrations;

(8) maintenance and maintenance methods, special storage conditions, methods;

(9) product technical requirements should be specified in the other content.

The second category, the third category of medical equipment should also indicate the medical device registration certificate number and medical device registrant name, address and contact information.

Medical devices that are used by consumers themselves should also have special instructions for safe use.

Article 32 The entrusted party shall be responsible for the quality of the medical equipment commissioned by the entrusted party, and the entrusted party shall be the manufacturer of the medical device with the corresponding production conditions in accordance with the provisions of these Regulations, and the entrusting party shall strengthen the production of the entrusted party Behavior management, to ensure that it is in accordance with the statutory requirements of production.

The high risk of implantable medical devices shall not be commissioned to produce, the specific directory by the State Council food and drug supervision and management departments to develop, adjust and publish.

Article 33 In the course of medical equipment business activities, there shall be a place of operation and storage conditions that are compatible with the scale of operation and scope of business, and the quality management system and quality management organization or personnel appropriate to the medical equipment to be operated.

Article 34 Whoever engages in the operation of the second type of medical device shall be filed with the food and drug supervision and administration department of the municipal people 's government at the district where the enterprise is located in the district where the enterprise is located and submit its proof of compliance with the conditions stipulated in Article 29 of these Regulations.

Operating in the circulation process through the regular management to ensure its safety and effectiveness of the second category of medical equipment, without the need for filing for the record of the second category of medical equipment product list by the State Council food and drug supervision and management departments to develop.

Article 35 Whoever engages in the operation of the third category of medical devices shall apply to the food and drug supervision and administration department of the municipal people 's government at the district where the district is located to apply for the business license and submit the supporting documents that meet the conditions stipulated in Article 29 of these Regulations The

The food and drug supervision and administration department that accepts the application for business license shall, within 30 working days from the date of acceptance, conduct the examination and, if necessary, organize the verification, and if the conditions are met, the license shall be granted and issued to the medical device business license; And will not give permission and explain the reasons in writing.

Medical equipment business license is valid for 5 years, the expiry of the validity period, in accordance with the relevant laws and regulations of the administrative permit for continuation procedures.

Article 36 Where a medical device business enterprise or a unit purchases a medical device, it shall examine the qualification of the supplier and the certificate of conformity of the medical device, and establish a system for checking the record of incoming goods, and shall engage in the wholesale business of the second and third categories of medical equipment As well as the third category of medical equipment retail business operators, should also establish a sales record system.

Record items include:

(A) the name of medical equipment, model, size, quantity;

(2) the production batch number, the validity period and the sales date of the medical equipment;

(3) the name of the manufacturer;

(4) the name, address and contact information of the supplier or purchaser;

(5) the relevant permit document number and so on.

The inspection records and sales records shall be true and kept in accordance with the time limit stipulated by the food and drug supervision and administration department under the State Council, and the state encourages the use of advanced technical means for recording.

Article 37 Transportation and storage of medical devices shall conform to the requirements of the medical device manual and the labeling design. If there are special requirements on environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 38 Medical equipment use units shall have storage facilities and conditions suitable for the variety and quantity of medical equipment used in the medical device. The medical device use unit shall strengthen the technical training for the staff and use it according to the requirements of the product manual and technical operation specification medical instruments.

Medical equipment use units to configure large-scale medical equipment, should be in line with the State Council department in charge of health planning to develop large-scale medical equipment configuration planning, and its functional positioning, clinical service needs to adapt, with the appropriate technical conditions, supporting facilities and have the appropriate qualifications, Technical personnel, and by the provincial people's governments above the provincial health department in charge of approval, access to large-scale medical equipment configuration permit.

The management of large-scale medical equipment shall be formulated by the competent department of health and family planning of the State Council in conjunction with the relevant departments under the State Council, and the catalog of large-scale medical equipment shall be submitted by the relevant department of the State Council department of health and family planning and promulgated to the State Council for approval.

Article 39 Medical devices All use of medical devices for repeated use shall be handled in accordance with the provisions on disinfection and management formulated by the department in charge of hygiene and hygiene of the State Council.

Disposable medical devices shall not be reused, and shall be destroyed and recorded in accordance with the relevant provisions of the State.

Article 40 Medical equipment use units shall carry out inspection, inspection, calibration, maintenance, maintenance and record of medical devices that need to be inspected, inspected, calibrated, maintained and maintained on a regular basis in accordance with the requirements of the product specification, and shall conduct timely analysis and evaluation, To ensure that the medical equipment in good condition, to ensure the use of quality; the use of long-term large-scale medical equipment, should be set up to use the file, record their use, maintenance, transfer, the actual use of time and other matters. Record life period shall not be less than medical equipment 5 years after the expiry of the term of use.

Article 41 The unit of use of medical devices shall properly preserve the original information on the purchase of medical devices of the third category and ensure that the information is traceable.

The use of large-scale medical equipment and implantation and intervention of medical equipment, medical equipment should be the name of the key technical parameters and information related to the use of quality and safety are closely related to the necessary information recorded in the medical records and other related records.

Article 42 Where a medical device is found to have a security risk, the medical device use unit shall immediately stop using it and notify the manufacturer or other agency responsible for the quality of the product to carry out overhaul; the medical equipment that has not been used to meet the safety standards, Do not continue to use.

Article 43 The department of food and drug supervision and administration and the department of hygiene and hygiene shall, in accordance with their respective duties, supervise and manage the quality of medical devices and the use of medical devices in the use of links.

Article 44 A medical device business enterprise or a unit of use shall not operate or use a medical device that has not been registered according to law, has no qualified documents, and expires, fails, expires, and has been used.

Article 45 A medical device use unit shall not use medical equipment that has not been registered according to law, has no qualified documents and expires, fails or expires.

The transfer of medical equipment between the use of units in the use of medical equipment, the transferor should ensure that the transfer of medical equipment is safe and effective, not transfer expired, expired, eliminated and tested unqualified medical equipment.

Article 46 Imported medical devices shall be medical devices that have been registered or have been filed in accordance with the provisions of Chapter II of these Regulations.

Imported medical devices should have Chinese manuals, Chinese labels, brochures, labels should comply with the provisions of this Ordinance and the relevant mandatory standards, and in the instructions listed in the medical device and the origin of the agent name, address, contact information. There is no Chinese manual, Chinese label or manual, the label does not meet the provisions of this article shall not be imported.

Article 47 Entry-exit inspection and quarantine institutions shall carry out inspection on imported medical devices according to law; if they are not qualified, they shall not import them.

The food and drug supervision and administration department of the State Council shall promptly notify the state entry-exit inspection and quarantine department of the registration and filing of the imported medical equipment.The entry and exit inspection and quarantine organ of the port of entry shall promptly inform the food and drug administration department of the municipal people's government Imported medical equipment clearance situation.

Article 48 An enterprise that exports medical equipment shall ensure that its medical equipment for export conforms to the requirements of the importing country (region).

Article 49 Advertisements in medical devices shall be true and lawful and shall not contain false, exaggerated and misleading contents.

Medical device advertising should be approved by the medical and pharmaceutical supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturer or the agent of the imported medical device is located, and the approval document of the medical device advertisement shall be obtained. The advertisement publisher shall publish the medical device advertisement, The approval of the document and its authenticity; shall not be issued without approval documents, the authenticity of the approval documents without verification or advertising content and approval documents inconsistent with the medical device advertising. Provinces, autonomous regions and municipalities directly under the Central Government food and drug supervision and management departments should be announced And update the approved medical device advertising catalog and approved advertising content in a timely manner.

The food and drug supervision and administration department of the people's government at or above the provincial level shall order the medical equipment for the production, sale, import and use to be suspended and shall not publish advertisements involving the medical device during the suspension period.

The examination and approval of medical device advertisement shall be formulated by the department of food and drug supervision and administration of the State Council in conjunction with the administrative department for industry and commerce under the State Council.

Article 50 The State shall establish a system for monitoring the adverse events of medical devices and collect, analyze, evaluate and control the adverse events of medical devices in time.

Article 51 A medical device registrant and a filing person shall be equipped with monitoring institutions and personnel with adverse events in conformity with their products and their size, and shall carry out adverse event monitoring on their products; if they find any adverse events or suspicious medical equipment adverse events, Should be in accordance with the provisions of the State Council food and drug supervision and management departments to the medical device adverse event monitoring technology institutions to report, and timely conduct investigation and evaluation, report the evaluation results, take the initiative to control product risk.

Medical equipment production and operation of enterprises, the use of units should be the production or operation of the use of medical equipment to carry out adverse event monitoring; found adverse medical devices or suspicious adverse events, should be timely feedback medical device registrants or filing, and in accordance with the State Council Food and Drug Administration Management department, report to medical device adverse event monitoring technical organization.

Any unit or individual found that medical device adverse events or suspicious adverse events, the right to the food and drug supervision and management or medical device adverse event monitoring technology institutions to report.

Article 52 The food and drug supervision and administration department of the State Council shall strengthen the construction of monitoring network of medical device adverse event monitoring information.

Medical device adverse event monitoring technology institutions should strengthen the medical device adverse event information monitoring, take the initiative to collect adverse event information; found adverse events or received adverse events reported, should be timely verification, investigation, analysis, assessment of adverse events, and to Food and drug supervision and management departments and health departments in charge of the proposed processing recommendations.

Medical device adverse event monitoring technology institutions should publish contact information to facilitate the production and operation of medical equipment business, the use of units such as reporting of medical equipment adverse events.

Article 53 The food and drug supervision and administration department shall, in accordance with the results of the evaluation of adverse events of medical devices, take timely warning information and order the suspension of production, sales, import and use of control measures.

The food and drug supervision and administration department of the people's government at or above the provincial level shall, in conjunction with the department in charge of health and family planning at the same level and relevant departments, timely investigate and deal with the adverse events of medical devices that caused serious and mass casualties or fatalities and promptly investigate and deal with the same kind of medical devices Strengthen monitoring.

Article 54 The medical device registrant, filing person, production and operation enterprise and user shall cooperate with the medical device adverse event investigation carried out by the medical device adverse event monitoring technical institution and the food and drug supervision and administration department.

Article 55 In any of the following circumstances, the registered person or the record holder of the medical device of the food and drug regulatory department of the people's government at or above the provincial level shall take the initiative to conduct the re-evaluation of the listed medical device for the registered medical device organization:

(1) According to the development of scientific research, there is an effective change in understanding of the safety of medical equipment;

(B) monitoring of adverse medical events, assessment results show that medical devices may be flawed;

(3) Other situations stipulated by the State Food and Drug Administration under the State Council that need reevaluation.

Medical device registrants or fillers failing to fulfill their obligation to re-evaluate medical devices, the food and drug regulatory departments at or above the provincial level shall order the medical device registrants or filing re-evaluation carried out.If necessary, the food and drug regulatory authorities above the provincial level Medical devices can be directly re-evaluation organizations.

The medical device registrant or the filing person shall make continuous improvement of the listed medical device according to the revaluation result and make the registration change or record change according to the stipulation.The revaluation result indicates that the registered medical device can not guarantee safe and effective, The medical device registrant or the filing person shall apply for cancellation of the registration certificate or cancel the record in time; if the medical device registrant or the filing person fails to apply for cancellation of the registration certificate or cancel the record, the original issuing department shall cancel the medical device registration certificate or cancel the record, The medical device that has been canceled or registered medical equipment shall not be produced, imported, operated or used.

Article 56 Where a medical device manufacturer or a filing person finds that the medical device produced by it is not in conformity with the mandatory standard, the technical requirements or other defects of the registered or filed product shall be stopped immediately and the relevant production and operation enterprise shall be notified , The use of units and consumers to stop the production and operation and use of the recall has been listed on the sale of medical equipment, to take remedial, destruction and other measures to record the relevant circumstances, the release of relevant information, and medical equipment recall and handling of food and drug supervision and management departments and Report of the Health and Welfare Department.

Medical equipment production and operation of enterprises found that the production and operation of medical devices exist in the provisions of the preceding paragraph, should immediately stop production and operation, notify the relevant production and operation of enterprises, the use of units, consumers, and record to stop the operation and notification of medical equipment manufacturers that Belong to the medical equipment that needs to be recalled in accordance with the provisions of the preceding paragraph and should be recalled immediately.

Where a medical device registrant or a filing person or a production and operation enterprise fails to implement the recall or ceases to operate in accordance with the provisions of this Article, the food and drug supervision and administration department may order it to recall or stop the operation.

Article 57 The State shall establish a specialized agency for the supervision and administration of food and drug administration by the people's government at or above the county level, with special personnel and undertake medical equipment inspection work. The food and drug administration department of the higher people's government may allocate the use of Inspectors of food and drug supervision and administration departments of the people 's governments at lower levels.

Food and drug supervision and management departments of the inspectors to implement classification management, and the establishment of assessment, compensation, promotion and other incentive and restraint mechanisms.

Article 58 The food and drug supervision and administration department shall strengthen supervision and inspection of the registration, filing, production, operation and use of medical devices, and carry out key supervision and inspection on the following matters:

(1) whether the registrant, filing person and the production enterprise of the medical device manufacturing enterprise organize the production according to the technical requirements of the registered or filed product;

(2) Whether the quality management system of the registrant, filing person and the production enterprise of the medical device manufacturing enterprise is kept in effective operation;

(3) Whether the conditions of production and operation of the registered persons, filing persons and production and operation enterprises of medical equipment production and operation enterprises continue to meet the statutory requirements.

Article 59 The food and drug supervision and administration department shall have the following functions and powers in the supervision and inspection:

(A) to enter the scene to implement inspection, sampling;

(2) to inspect, copy, seize and seize the relevant contracts, bills, books and other relevant information;

(3) seizure and seizure of medical devices that are not in conformity with the statutory requirements, spare parts for illegal use, raw materials and tools and equipment for the illegal production of medical devices;

(4) to quarantine the place where the medical device is engaged and operated in violation of the provisions of these Regulations.

Food and drug supervision and management departments to carry out supervision and inspection, should produce law enforcement documents, conservative inspection of the trade secrets.

The relevant units and individuals shall cooperate with the supervision and inspection of food and drug supervision and administration departments and shall not conceal the relevant situation.

Article 60 Medical equipment and food and drug supervision and administration departments that may cause harm to the human body or prove that they may endanger human health may take emergency control measures to suspend production, import, operation and use.

Article 61 The food and drug supervision and administration department shall strengthen the examination and examination of medical equipment for the production, operation and use of medical equipment production and operation enterprises and the use units, and the inspection fees shall not be charged for inspection fees and any other expenses, The food and drug supervision and administration departments of the people 's governments at or above the provincial level shall promptly publish the medical equipment quality bulletin according to the conclusions of the spot checks.

The department of hygiene and hygiene shall supervise and evaluate the use of large-scale medical equipment; if it is found that illegal use and excessive examination and over-treatment related to large-scale medical equipment should be corrected immediately and dealt with according to law.

Article 62 The accreditation work of a medical device inspection institution shall be carried out in accordance with the relevant provisions of the State, and the inspection and administration department of the State Council shall, in conjunction with the inspection agency approved by the food and drug supervision and administration department under the State Council, carry out the examination of the medical device.

Food and drug supervision and management departments in the law enforcement work need to test the medical equipment, should be commissioned by a qualified medical device inspection agencies, and pay the relevant costs.

If the party concerned has any objection to the test result of the medical device inspection institution, the party concerned may, within 7 working days from the date of receipt of the test result, examine the qualified medical device inspection institution for re-examination, and submit to the State Council for Food and Drug Administration Published in the list of re-inspection agencies in the medical device inspection agency to submit a re-examination application.Application of the applicant did not submit a re-examination of the test results, and the medical device inspection agency undertaking the re-examination work should be in the State Council Food and Drug Administration Department of the provisions of the time to make a review conclusion.The review conclusion for the final test conclusion.

Article 63 For medical devices that may have harmful substances or alter medical equipment design, raw materials and production processes and have hidden safety problems, according to the medical equipment national standards, industry standards of inspection items and test methods can not be tested, medical equipment Inspection agencies can supplement the test items and test methods for testing; use of supplementary test items, test methods concluded by the inspection and approval of the State Council food and drug supervision and management departments, food and drug supervision and management departments can be identified as the basis for the quality of medical equipment.

Article 64 The food and drug supervision and administration departments of the municipal and county people's governments at the municipal level shall strengthen the supervision and inspection of the advertisements of medical devices and discover that the medical device advertisements without approval or tampering with the approved advertisement contents shall be sent to the local province , Autonomous regions and municipalities directly under the Central People's Government food and drug supervision and management departments report, by its announcement to the community.

The administrative department for industry and commerce shall, in accordance with the provisions of the relevant laws and administrative regulations on advertising administration, supervise and inspect the medical device advertisements and investigate and deal with the illegal acts, and the food and drug supervision and administration department shall report the illegal operation of the medical device advertisement and submit the processing proposal and follow the relevant procedures Transfer to the same level of industrial and commercial administration.

Article 65 The food and drug supervision and administration department of the State Council shall establish a unified information and supervision and management information platform for medical devices, and the food and drug supervision and administration departments shall, in accordance with the law, timely publicize the daily supervision and management of medical equipment such as permitting, filing, spot checks and inspections But may not divulge the trade secrets of the parties.

Food and drug supervision and management departments of medical equipment registrants and filing, production and operation of enterprises, the use of units to establish credit files, there are bad credit records to increase the frequency of supervision and inspection.

Article 66 Food and drug administration and other departments shall make public the contact information of their own units and shall receive advice, complaints and reports, and other departments in charge of food and drug supervision and management shall timely reply their inquiries concerning the supervision and administration of medical devices; if they receive a complaint , And shall report, promptly verify, deal with, reply to the consultation, complaint, report the situation and the reply, verification, handling, it should be recorded and preserved.

Where reports of the development, production, operation and use of medical devices have been investigated, the department in charge of food and drug administration shall give rewards to whistleblowers.

Article 67 The food and drug regulatory department under the State Council shall solicit public opinions for formulating, adjusting and revising the catalogs as prescribed in these Regulations and the norms governing the supervision and administration of medical devices. Hearings of experts and medical devices Production and operation of enterprises and the use of units, consumers and related organizations and other aspects of the views.

Article 68 Any one of the following circumstances shall be confiscated by the food and drug supervision and administration department of the people's government at or above the county level for confiscation of illicit gains, illegal production and operation of medical equipment and tools, equipment and raw materials for illegal production and operation; Where the value of the medical equipment under management is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the value of the medical equipment is over 10,000 yuan, a fine of not less than 10 times but not more than 20 times the value of the goods shall be imposed; if the case is serious , 5 years not to accept the responsible persons and companies to apply for permission to apply for medical equipment:

(1) The production and operation of medical devices of the second and third categories which have not obtained the medical device registration certificate;

(2) engaging in the production of the second and third types of medical devices without permission;

(3) engaging in the operation of the third type of medical device without permission

In the first paragraph of the preceding paragraph, if the circumstances are serious, the original license-issuing department shall revoke the medical device manufacturing license or the medical device business license.

Unauthorized use of large-scale use of medical equipment, by the people's governments at or above the county level health department heads ordered to stop using, give a warning, confiscate the illegal income; illegal income of less than 10,000 yuan, and more than 10,000 yuan more than 50,000 yuan Fines; illegal income of more than 10,000 yuan, and more than 5 times the illegal income of 10 times the fine; the circumstances are serious, 5 years will not accept the relevant responsible persons and units of large medical equipment configuration permit application.

Article 69 Where a false information or other deceptive means is used to obtain a medical device registration certificate, a medical device production license, a medical device business license, a large medical equipment configuration permit, and an advertising approval document, The department shall revoke the license that has been obtained and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan, and shall not accept the application for medical device application for the relevant person and unit within 5 years.

If the illegal income is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; if the illegal income is less than 10,000 yuan, the original license department shall collect or revoke or confiscate the illegal income; The illegal income of more than 10,000 yuan, the illegal income of 3 times more than 5 times the fine; constitute a violation of public security management behavior, the public security organs shall be punished according to law and order.

Article 70 Where the record is not filed in accordance with these Regulations, the food and drug supervision and administration department of the people 's government at or above the county level shall order it to make corrections within a prescribed time limit. If it fails to make corrections within the time limit, it shall be imposed a fine of not more than 10,000 yuan for public declaration of the unit and product name.

Where a false information is provided at the time of filing, the food and drug supervision and administration department of the people's government at or above the county level shall notify the society of the record unit and the product name; if the circumstances are serious, the directly responsible person shall not engage in the production and operation of medical equipment within 5 years.

Article 71 In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall order it to make corrections and confiscate the medical devices that are illegally produced, operated or used; the amount of medical equipment produced illegally produced, operated or used is insufficient 1 yuan, and impose a fine of 20,000 yuan to 50,000 yuan; the amount of the amount of more than 10,000 yuan, and the amount of the amount of the amount of 5 times more than 10 times the fine; the circumstances are serious, ordered to stop production until the original The issuing department revoked medical device registration card, medical equipment production license, medical equipment business license:

(1) to produce, operate or use medical devices that do not meet the mandatory standards or do not meet the technical requirements of the registered or filed product;

(2) The registrant or filing person of the medical device or the manufacturer shall not organize the production according to the technical requirements of the registered or filed product or fail to establish the quality management system and maintain the effective operation in accordance with the provisions of these Regulations;

(3) to operate and use the non-qualified documents, expired, expired, eliminated, used medical devices, or the use of medical devices that are not legally registered;

(4) the food and drug supervision and administration department shall order it to refuse to recall or stop the operation of medical equipment after the implementation of the recall or stop operation in accordance with the provisions of these Regulations;

(5) to entrust an enterprise that does not have the conditions prescribed in these regulations to produce medical equipment or to not manage the production behavior of the entrusted party.

The import of medical equipment, its production in violation of the relevant provisions of Article 28 of these regulations, according to the law to make interviews, deadline for rectification, issuing letters, suspended imports, supervision of recall products, suspension of sales use, not to continue to register and other decisions; If the circumstances are serious, the medical device registration certificate or cancellation certificate can be revoked.

Medical equipment business, the use of units to fulfill the provisions of the provisions of the purchase inspection and other obligations, there is sufficient evidence that they do not know the operation, the use of medical equipment for the first paragraph of the first paragraph, the third provisions of the situation of medical equipment, and Truthfully stated that the source of its purchase, can be exempted from punishment, but should be confiscated according to their business, the use of non-compliance with the statutory requirements of medical equipment.

Article 72 In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall order it to make corrections and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and cease business until the original certificate Department revoked medical equipment production license, medical equipment business license:

(1) The production conditions of medical equipment manufacturing enterprises are changed and are no longer in conformity with the requirements of the medical equipment quality management system and have not been rectified and stopped in accordance with the provisions of these Regulations.

(2) the production and operation of the instructions and the labeling does not conform to the medical devices prescribed in these Regulations;

(3) failing to transport and store medical equipment in accordance with the instructions and labeling of medical devices;

(4) Transfer of expiry, expiry, elimination or inspection of unqualified medical equipment.

Article 73 In any of the following circumstances, the food and drug supervision and administration departments of the people's governments at or above the county level shall, in accordance with their respective duties, order them to make corrections and give a warning; if they refuse to make corrections, they shall be at the rate of not less than 5,000 yuan but not more than 20,000 yuan Fine; the circumstances are serious, ordered to suspend production, until the original issuing department revoked medical equipment production license, medical equipment business license:

(1) the medical device registrant or filing person, the production enterprise fails to submit the self-examination report of the quality management system as required;

(2) Where a medical device business enterprise or a unit of use has not established and implemented a medical device inspection record system in accordance with the provisions of these Regulations;

(3) The business enterprise engaged in the wholesale business of the second and third categories of medical devices and the retail business of the third category of medical devices has not established and implemented the sales record system in accordance with the provisions of these Regulations;

(4) For the repeated use of medical equipment, medical equipment use units are not in accordance with the provisions of disinfection and management of the treatment;

(5) The medical device use unit reuses the disposable medical device or fails to destroy the disposable medical device used in accordance with the regulations;

(6) For medical devices and medical devices that need to be inspected, inspected, calibrated, maintained and maintained on a regular basis, they are not inspected, tested, calibrated, maintained, maintained and recorded in accordance with the product specifications. In good condition

(7) The medical device use unit does not properly store the original data of the third type of medical equipment, or fails to record the information of the large medical device and the medical device of implantation and intervention into the medical records and other relevant records;

(8) the use of medical devices found in the use of medical equipment, there are security risks are not immediately stop using, notify the maintenance, or continue to use the maintenance can not meet the use of safety standards of medical equipment;

(9) the use of medical equipment units illegal use of large medical equipment, can not guarantee the quality of medical safety;

(10) Medical devices Registered persons or filing persons, production and operation enterprises, the use units did not monitor the adverse events of medical devices in accordance with the provisions of these Regulations, fail to report adverse events according to the requirements, or monitor the technical institutions of medical devices, food and drug supervision and management Departments to carry out the investigation of adverse events do not cooperate.

Article 74 Where a registrant or a record holder of a medical device fails to carry out the re-evaluation of the medical device in accordance with the provisions of these Regulations and hides the result of the re-evaluation, it shall file an application for cancellation but fails to submit it or re-evaluate the medical device organized by the food and drug regulatory department Those who fail to cooperate shall be ordered by the local people's government at or above the county level to supervise the food and drug administration for correction and given a warning; if they refuse to make corrections, they shall be fined not less than 5,000 yuan and not more than 20,000 yuan and the original registration or filing department shall make a cancellation of the registration of medical devices Certificate or decision to cancel the record, and timely publicity to the community.

Article 75 Where an imported medical device agent fails to perform relevant duties in accordance with the provisions of these Regulations, the food and drug administration at or above the county level shall give a warning and order it to make corrections, and may concurrently impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; Corrections shall be ordered to suspend the import of relevant medical devices; if the circumstances are serious, the agency and the relevant responsible person shall not engage in activities related to the import of medical device agents within 5 years.

Article 76 Anyone who carries out clinical trials of medical devices in violation of the provisions of these Regulations shall be ordered by the food and drug supervision and administration department of the people's government at or above the county level to make corrections or immediately stop the clinical trial and may be fined not more than 50,000 yuan. Where any serious consequences are caused, Directly in charge of managers and other directly responsible personnel demotion, dismissal or dismissal of punishment; the agency shall not be carried out within 5 years of professional medical device clinical trials.

Where a clinical trial institution of a medical device issues a false report, the food and drug supervision and administration department of the people's government at or above the county level may impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; confiscating the illegal gains if the illegal proceeds are obtained; and directly supervising the supervisor and other direct Responsible persons, according to the law to give dismissal or dismissal of the punishment; the agency shall not be carried out within 10 years of professional clinical trials of medical devices.

Article 77 Where a medical device inspection agency issues a false inspection report, the competent department that granted the qualification shall revoke the examination qualification and shall not apply for accreditation within 10 years; a fine of not less than 50,000 yuan but not more than 100,000 yuan and a fine of not more than 100,000 yuan , The illegal gains shall be confiscated; the directly responsible supervisors and other personnel directly responsible shall be dismissed or dismissed according to law; and those who are subject to dismissal shall not engage in medical device inspection within 10 years from the date of the decision on punishment.

Article 78 Anyone who, in violation of the provisions of these Regulations, publishes an advertisement for a medical device without obtaining the approval document, issues an advertisement for the medical device without prioritizing the authenticity of the approval document, or advertises a medical device whose advertisement content is inconsistent with the approval document, Administrative departments shall punish according to the laws and administrative regulations on advertisement management.

If the approved medical device advertisement content is tampered with, the original license-issuing department shall withdraw the advertisement approval document of the medical device and shall not accept the advertisement approval application within 2 years.

Where an advertisement for a fake medical device is issued, the food and drug supervision and administration department of the people's government at or above the provincial level shall decide to suspend the sale of the medical device and announce it to the public. Where the medical device is still being sold, the food and drug supervision and administration department of the people's government at or above the county level shall confiscate the illegal Sales of medical equipment, and 20,000 yuan more than 50,000 yuan fine.

Article 79 In case of any one of the following circumstances in violation of the provisions of this Law, medical device registrants, record fillers, production and business enterprises and users in violation of the provisions of this Law may also punish their units in accordance with the aforementioned provisions of this Chapter, and may also punish legal representatives, The person in charge, the person in charge directly in charge and other directly responsible personnel shall be punished with a fine of not less than 30% but not more than 1 times the income of the previous year:

(A) deliberate implementation of illegal acts or there is a gross negligence;

(2) The illegal act is in serious circumstances and of a poor nature;

(3) If the illegal act has caused serious consequences or other serious adverse social impacts.

Article 80 Where a medical device technical examination institution or a medical device adverse event monitoring and technical institution fails to perform its duties in accordance with the provisions of these Regulations and causes major mistakes in the examination and monitoring work, the food and drug supervision and administration department of the people's government at or above the county level shall order it to make corrections , To inform the criticism, to give a warning; cause serious consequences, the directly responsible person in charge and other directly responsible personnel, according to the law to give demotion, dismissal or dismissal punishment.

Article 81 The department of food and drug supervision and administration, the department of health care and its staff shall, in strict accordance with the types and extent of the punishment prescribed in these Regulations, exercise the right of administrative punishment according to the nature and specific circumstances of the illegal act. The specific measures shall be prescribed by the State Council Food and Drugs Supervision and management departments, health and subsistence authorities in accordance with their respective responsibilities to develop.

Article 82 Whoever violates the provisions of these Regulations, the food and drug supervision and administration department or other relevant departments of the people's governments at or above the county level shall not be responsible for the supervision and administration of medical devices or abuse their duties, neglect their duties and engage in malpractices for personal gains, and shall be directly responsible by the supervisory organ or the abolition organ The person in charge and other persons directly responsible shall be given a warning, remembered or remembered punishable in accordance with the law; if any serious consequences are caused, the demotion, dismissal or dismissal shall be given.

Article 83 Whoever, in violation of the provisions of these Regulations, constitutes a crime shall be investigated for criminal responsibility according to law; if he causes personal property, property or other damage, he shall be liable for compensation according to law.

Article 84 The meanings of the following terms in this Ordinance are as follows:

Medical devices refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are used directly or indirectly for the human body, including the required computer software; their utility is obtained primarily by physical means, Not through pharmacological, immunological or metabolic methods, or, although there are these ways to participate but only play a supporting role; its purpose is:

(A) the diagnosis, prevention, monitoring, treatment or remission of the disease;

(2) the diagnosis, monitoring, treatment, remission or functional compensation of the injury;

(3) the examination, substitution, regulation or support of the physiological structure or physiological process;

(4) the support or maintenance of life;

(5) pregnancy control;

(Vi) Provide information for medical or diagnostic purposes by examining samples from the human body.

Medical devices use units, refers to the use of medical equipment for others to provide medical and other technical services, including access to medical institutions permit medical institutions, access to family planning technical service agencies permit the family planning technical service agencies, and according to the law is not Need to obtain medical institutions permit the blood bank, single plasma stations, rehabilitation aids and other institutions.

Large medical equipment, refers to the use of complex technology, capital investment, high operating costs, the impact of large medical expenses and into the directory management of large medical equipment.

Article 85 The fees and charges for the registration of medical device products shall be charged, and the specific charges and standards shall be formulated by the financial and pricing departments under the State Council in accordance with the relevant provisions of the State.

Article 86 Measures for the Administration of Nonprofit Contraceptive Medical Devices and Measures for the Administration of Medical Devices developed by medical and health institutions in response to public health emergencies shall be formulated by the Food and Drug Administration of the State Council in conjunction with the department of hygiene and family planning of the State Council.

Chinese medicine medical equipment management approach, by the State Council food and drug supervision and management departments in conjunction with the State Council medicine The administrative department of the State Council shall, in conjunction with the civil affairs department under the State Council, be formulated in accordance with the provisions of these Regulations. The scope of the medical equipment for the rehabilitation of auxiliary equipment shall be formulated in accordance with the provisions of these Regulations.

Article 87 The supervision and administration of the use of military medical equipment shall be organized and implemented by the military health administrative departments in accordance with these Regulations and the relevant provisions of the armed forces.

Article 88 These Regulations shall enter into force as of June 1, 2014.