Measures for the Supervision and Administration of Imported Medical Device Agents

Medical Network August 4th News On August 3, the State Food and Drug Administration issued a letter on the "Opinions on the Supervision and Administration of Imported Medical Device Agents" and attached the "Administrative Measures on the Supervision and Administration of Imported Medical Device Agents (Draft for Comment)" (hereinafter referred to as the opinion draft).

The opinion draft clearly stipulates the conditions and obligations of the agent, and also requires the provincial level. drug The supervisory and administrative department shall collect and collect in time proxy In the case of the person, the list of agents in the administrative area is published, on-site verification is carried out, and the agent's annual self-examination report is reviewed.

The original draft of the opinion is as follows:

Article 1 In order to strengthen the supervision and management of imported medical devices, regulate the behavior of imported medical device agents, and ensure the safety and effectiveness of imported medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 The import medical device agent (hereinafter referred to as the agent) referred to in these Measures refers to the representative office of the overseas medical device listing permit holder who points to the export of medical devices in China or is authorized to be the only one in China. enterprise Legal person. The name of the agent, address and contact information are listed in the medical device registration certificate or filing information.

Hong Kong, Macao, Taiwan sell medical equipment to the mainland, and refer to these Measures for management.

Article 3 The agency activities and supervision and management of holders of overseas medical device listing licenses within the territory of the People's Republic of China shall abide by these Measures.

Article 4. The State Drug Administration is responsible for guiding the supervision and administration of national agents.

The provincial drug supervision and administration department is responsible for the supervision and management of the agents in the administrative area.

Article 5 Agents shall abide by the Laws of the Medical Device Supervision and Administration and other laws. Regulation The relevant regulations are responsible for the authenticity and legality of the work related to the products being represented, and bear legal responsibility for the relevant actions of the agent products.

(1) The representative office established by the holder of the overseas medical device listing permit in China or the only legal person in China authorized by it;

(2) Having a quality management system that is compatible with the work of the agency, and having a quality management personnel or a quality management organization that is compatible with its scale, the quality management personnel shall have the ability to perform the corresponding quality management duties, possess regulatory knowledge and relevant professional knowledge;

(3) having an office space that is compatible with the agency work;

(4) having a computer information management system that satisfies the traceability requirements of the agent product;

(5) Other conditions stipulated by the drug regulatory authority.

(1) Handling medical device registration or filing affairs in accordance with regulations;

(2) To undertake the monitoring and reporting of adverse medical events for imported medical devices sold in China, and to inform the holders of overseas medical device marketing licenses of domestic adverse event information, and cooperate with the investigation of adverse events conducted by medical device adverse event monitoring agencies and drug regulatory authorities. And timely report to the drug regulatory authority the medical device adverse events occurring outside the country as required;

(3) Undertaking the recall of the product after the listing of the medical device, and reporting to the drug regulatory authority;

(4) Assisting the drug regulatory authority to carry out inspections and violations of the holders of overseas medical device marketing licenses;

(5) Cooperating with the drug supervision and administration department to carry out supervision and management of medical device product quality supervision, inspection and evaluation, and provide relevant information and information;

(6) Master the import status of the imported medical equipment and the sales and distribution in China, and ensure that the products can be traced back;

(7) Responsible for liaison between the drug regulatory authority and the holder of the overseas medical device listing permit, and timely inform the holder of the overseas medical device listing permit to the relevant laws, regulations and technical requirements;

(8) Urging and assisting holders of overseas medical device marketing licenses to complete the contents of the registration certificate containing conditional approval;

(9) Investigating and handling consumer complaints, and reporting the results to the complainant, collecting and summarizing the complaint information and promptly feedback the holder of the overseas medical device listing permit;

(10) Joint liability for the violation of the product quality and related services, and the holder of the overseas medical device listing permit;

(11) Other obligations as stipulated by the drug regulatory authority.

Article 8 Where the name, residence and contact information of the holders and agents of medical device listing licenses change, the agent shall promptly change the registration items or change the filing information to the State Drug Administration.

Article 9 When overseas medical devices are withdrawn from the domestic market, the agent shall submit the management plan for the quality claim and recovery, maintenance, adverse event monitoring, recall, etc. of the after-sales products to the local provincial drug administration.

Article 10 If the holder of the overseas medical device listing permit changes the agent, the new agent shall be entrusted to the State Drug Administration to handle the change of registration or change the filing information, and the authorization letter of the holder of the overseas medical device listing permit shall be clearly stated. The termination date of the outgoing agent shall be the authorization start date of the new agent. The original agent shall also submit the relevant agent's termination agreement when the application is completed; if the original agent's termination agreement cannot be submitted, the holder of the overseas medical device listing permit shall Explain. The agent's responsibility shall be borne by the new agent from the date of completion of the change of registration or change of the filing information.

Article 11 If the holder or agent of a listing permit for overseas medical devices is investigated by the drug supervision and administration department for violation of laws and regulations but has not yet completed the case, or has received an administrative penalty decision but has not fulfilled it, and has not completed the change of the agent, the original agent The obligation should continue to be fulfilled.

Article 12 An agent who manages the imported medical devices that he represents shall handle the business license and record in accordance with relevant regulations.

Article 13 An agent shall conduct self-inspection on its own operation, conditions and statutory obligations, and submit an annual self-inspection report to the local provincial drug regulatory authority before the end of each year.

The agent shall submit a self-examination report on the agency information and the holder of the overseas medical device marketing permit to the provincial drug regulatory authority at the end of the year before the end of the year.

Article 14 If an agent discovers the Chinese manual for imported medical devices, if the contents of the Chinese label are inconsistent with the relevant contents of the registration or filing, it shall promptly inform and urge the holder of the overseas medical device listing permit to correct it.

Article 15 The State Drug Administration shall promptly report the agent information to the provincial drug regulatory authority where the agent is located.

Article 16. The provincial drug supervision and administration department shall promptly collect and summarize the situation of the agent, publish the directory of agents in the administrative area, conduct on-site inspection, and review the agent's annual self-inspection report.

Article 17 The provincial drug supervision and administration department shall formulate the supervision and inspection plan of the agent in the administrative area, check the frequency and key points, and organize the implementation. The supervision and inspection shall truthfully record the on-site inspection and inform the agent in writing of the inspection result. 1. The content of the rectification and the time limit for rectification should be clarified, and follow-up inspection should be carried out.

When the provincial drug supervision and administration department supervises and inspects the agent, it may conduct an extension inspection of the relevant medical device management enterprise, maintenance service organization, and use unit.

Article 18 The provincial drug supervision and administration department shall establish an agent supervision file, record the results of daily supervision and inspection, investigate and deal with violations, etc., and implement key supervision of agents with bad credit records.

Article 19 If the agent's registration information cannot be contacted, the provincial drug regulatory authority may take emergency measures such as suspending import and sales.

Article 20 In any of the following circumstances, the provincial drug supervision and administration department may, according to its duties, conduct an interview with its legal representative or principal responsible person:

(1) The quality and safety of medical devices may cause medical device quality and safety risks;

(2) The quality of medical devices that fail to properly handle complaints in a timely manner may have potential risks to the safety of medical devices;

(3) failing to take effective measures to promptly eliminate the hidden dangers of quality and safety of medical devices, and failing to fulfill the responsibility for quality and safety of medical devices;

(4) In the process of registering medical devices, submit false registration materials to defraud the registration certificate;

(v) Other circumstances in which interviews are required.

The interview does not affect the drug supervision and administration department to carry out administrative treatment according to law, and the interview situation and follow-up treatment can be disclosed to the public.

If the agent fails to implement the rectification without any justification, the provincial drug supervision and administration department shall investigate and deal with it according to the law, and increase the frequency of supervision and inspection according to the duties.

Article 21 If one of the following circumstances exists, the provincial drug supervision and administration department may list the legal representative or principal person in charge of the agent into the list of untrustworthy enterprises and untrustworthy persons, and disclose it to the public:

(1) Being sentenced to a fixed-term imprisonment or more for the crime of quality and safety of medical devices;

(2) Violating the relevant laws and regulations on medical devices, and the circumstances are serious, and the punishment is revoked or the license is cancelled and the record is cancelled;

(3) Violating the relevant laws and regulations on medical devices, and the circumstances are serious, and may not be dealt with in the production and operation of medical devices;

(4) Refusing to implement the decision to suspend import and sales;

(5) After the company is interviewed, it refuses to rectify it as required.

Article 22 If an agent engages in agency activities in violation of the relevant provisions of laws and regulations, and has been stipulated by laws and regulations, it shall be prescribed by it. If it constitutes a crime, it shall be transferred to the relevant department according to law.

Article 23 If the agent fails to perform the obligations related to (1), (2), (3), (4), (5) and (6) of Article 7 of these Measures, the provincial drug supervision and administration department shall A fine of not less than 20,000 yuan but not more than 30,000 yuan. If the circumstances are serious, the provincial drug regulatory authority may take emergency measures such as suspending import and sales.

If the agent fails to perform the obligations related to (7), (8), (9) and (11) of Article 7 of these Measures, the provincial drug supervision and administration department shall give a warning and order it to make corrections. The following fine.

Article 24 If the name, address and contact information of the agent change, if it fails to change according to the regulations, the provincial drug supervision and administration department shall order it to make corrections and give a warning; if it refuses to make corrections, it shall be fined not more than 10,000 yuan.

Article 25 If an agent has any of the following circumstances, the provincial drug supervision and administration department shall give a warning, order it to make corrections within a time limit, and refuse to make corrections, and impose a fine of 5,000 yuan or more and 20,000 yuan or less:

(1) The agent has not established and implemented the quality management system as required;

(2) The agent fails to set up a quality management organization or quality management personnel that is appropriate to its scale as required;

(3) The agent's computer information management system cannot meet the quality management requirements.

(4) Failure to submit the self-inspection report as required, relevant agency information, self-examination report of the holder of the overseas medical device marketing permit.

Article 26 If the staff of the provincial drug supervision and administration department responsible for supervising the agent fails to perform their duties or abuse their powers, neglect their duties, and engage in malpractices for personal gains, they shall be investigated for administrative responsibility according to law; if they constitute a crime, they shall be transferred to the judicial organs for criminal responsibility.

Article 27 If a medical device product or service provided by an agent causes personal or property damage, it shall bear civil liability in accordance with the provisions of relevant laws and regulations.

Article 28 These Measures shall come into force on the day of the month of 2018.