Reconsideration of Medical and Mechanical Regulations | Fines rise, personal fines, and even lifelong bans

According to the medical network of June 26, the “Regulations for the Supervision and Management of Medical Devices” (hereinafter referred to as the "Regulations"), which are called the "industry mother law," have been amended again. There have been significant changes.

In particular, individuals should pay attention to the plan to increase the number of penalties imposed on individuals, and raise the standards of penalties for enterprises. The industry's supervision has never been stricter!

The “Regulations” was started in 2000 and was completely revised in 2014. In May 2017, a partial amendment was made. This time, it is to be revised again. It is done in the form of an 'Amendment'.

Last November, original food drug The General Administration of Supervision has publicly solicited opinions on the Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft Consultation Draft). On this basis, in conjunction with the institutional reform plan for April this year, the “Amendment to the Regulations on the Supervision and Administration of Medical Devices” has been drafted (draft). Submitted for review).

On June 25, the Ministry of Justice announced that the General Administration of New Market Supervision submitted to the State Council for review and approval of the "Amendment of Medical Device Supervision and Administration Regulations (Draft for Ratification)" and publicly solicit opinions.

The deadline for soliciting opinions is July 24, 2018. This shows that the process of revising the "Regulations" has gone one step further. It is not too far from the State Council's deliberation and approval.

First, the implementation of the last year's China Office in October last year, issued by the State Council to encourage the innovation of medical device 36, the current "Regulations" inconsistent content to be amended to supplement the relevant provisions.

The second is to carry out some targeted supplements to the outstanding problems in the supervision practice, some of the punishment standards have become heavy, and the provisions to increase punishment to people.

In comparison with the current “Regulations”, the “Draft Amendment Draft” of the Regulations published by the Ministry of Justice contains 12 more drafts, 2 articles deleted and 39 articles amended. The main changes include:

With respect to the system of license holders of medical devices that loosen their registration and production, the "Draft Draft" is stipulated in special articles, and the obligations and main responsibilities of the holders are clearly defined.

The "Draft amendment" makes it clear that holders of marketing licenses can produce and sell their own products, and they can also entrust other companies to produce and sell products.

For overseas registrants and archivists who have difficulties in supervision and punishment, the management regulations for overseas listing license holders in the country are increased, their obligations are clarified, and corresponding penalty clauses are added.

If the import agent fails to fulfill his obligations, he shall be given a warning, ordered to make corrections, and fined 3 to 10 thousand yuan; if he refuses to make corrections, the fine shall be 100,000 to 200,000, and the import of the product shall be suspended; if the circumstances are serious, the industry shall be banned for 5 years.

The approval of clinical trials for the third category of high-risk products was changed from an express license to an implicit license.

Increase the acceptance of overseas clinical trial data, and expand the regulations for clinical use.

It is not necessary to carry out clinical evaluation to clarify the registration of a class of device products; in principle, Class II device registration does not require clinical evaluation; three types of devices should be evaluated clinically unless otherwise specified.

The second category medical instruments The review and appraisal of the product registration shall be implemented by the provincial drug administration department and replaced by the State Food and Drug Administration.

For domestic and foreign innovative medical devices that are not listed, they are no longer required to provide proof of overseas sales.

Add a paragraph: For the treatment of rare diseases, serious life-threatening and there is no effective treatment means of disease, to deal with public health emergencies urgently needed medical equipment conditional approval, and the validity of the registration certificate is flexible.

5, Part of the second type of equipment, no need to record to operate

Add a paragraph: The second type of medical equipment that can guarantee the safety and effectiveness through regular management does not need to go through the operation record. The specific directory is formulated by the State Food and Drug Administration.

(Note: For medical devices such as clinical thermometers and condoms, most supermarkets and convenience stores have operations, and the risk of circulation is small.)

Current law Regulation Without clearly forbidding the import and sale of used medical devices, the list of used mechanical and electrical products that are prohibited from importation by the General Administration of Quality Supervision, Inspection and Quarantine, and the General Administration of Customs, etc., cannot cover most medical devices. It is difficult to deal with the illegal import of used medical devices. Outstanding problems.

The "draft amendment" explicitly adds a paragraph: 'Prohibition of the import and sale of used medical devices.'

Cancel pre-examination and post-regulation by the market supervision department.

The unlicensed medical devices seized in the regulatory practice cannot be tested because there are no relevant standards; some counterfeit and legitimate enterprise The product may have passed the test results, which may lead to difficulty in investigation and punishment.

The "Amendment Bill" added: "Prohibit the production, operation, use of counterfeit medical devices." and specify the specific circumstances of counterfeit medical devices.

One of the following situations is false medical equipment:

(1) Produced and imported without obtaining medical device registration certificate or filing certificate;

(b) Impersonating a medical device with a non-medical device, or impersonating such a medical device with another medical device;

(3) To take fraudulent means to obtain the medical device registration certificate or record vouchers for production and import;

(4) Counterfeiting, fraudulent use of medical device registration certificate or registration certificate, company name, production address, etc. '

Clearly stipulates: Medical device development activities are supervised and inspected by the State Food and Drug Administration; Production activities are supervised by drug supervisors at or above the provincial level; Operation and use activities are undertaken by the city and county level; Overseas inspections are organized by the State Food and Drug Administration.

9. Fines standards have been greatly increased, and penalties have been increased

For production and trading of counterfeit medical devices, production and business activities without permission: The value of goods is within 10,000 yuan, the fine rate is from 50,000 yuan to 100,000 yuan, the value of goods is over 10,000 yuan, and the fine is The standard is 10-20 times the value of the goods, and is adjusted to 15-30 times the value of the goods.

For the provision of false information on the provision of false information or other fraudulent means, the minimum fine shall be adjusted from 50,000 to 100,000.

For counterfeiting, altering, buying, selling, renting, lending of relevant medical device licenses: illegal income less than 10,000 yuan, fines ranging from 1 to 30,000 to 100,000 to 150,000; illegal gains to more than 10,000, fines to 3 -5 times, adjusted to 15-30 times.

If a medical device manufacturing enterprise fails to file the record according to regulations, the fine rate shall be less than 10,000 yuan and shall be adjusted to 50,000 yuan or less. False information shall be provided for the record, if the production and business operations are already carried out, the illegal proceeds and products shall be confiscated and fined. Provisions.

Newly incorporated two kinds of illegal activities, the company refused to correct the fine of 5000-2 million yuan, the circumstances of severe suspension of production and business suspension, and even the cancellation of the certificate. These two kinds of behaviors include: From the non-qualified holders of medical device marketing, If an enterprise purchases a medical device; fails to carry out a re-evaluation of the medical device as prescribed and hides the re-evaluation result, it shall file an application for cancellation without raising it, or it will not cooperate with the medical device re-evaluation conducted by the drug administration organization.

The punishment for the four kinds of illegal acts was added to the regulation of 'industry banned from direct responsibility within three years'. These four kinds of behaviors include: Changes in the production conditions of medical devices, no longer meet the requirements of the medical device quality management system, not according to regulations Rectify, stop production, report; production, operating instructions, labels that do not meet the requirements of medical devices; fail to comply with medical device instructions and labeling requirements for transportation, storage of medical devices; transfer expired, expired, eliminated or ineligible With medical instruments.

Add 6 kinds of illegal acts to be included, order them to make corrections, confiscate the illegal products, and impose fines (250,000 to 50,000 for fines worth less than 10,000; 5-10 times fine for goods worth 10,000 or more), and the circumstances are serious. It also suspends production, suspends operations, even revokes certificates, and cancels filings. Directly responsible persons are banned from the industry within five years. These six types of behaviors include: Failure to formulate a post-listing continuous research and risk management plan and ensure its effective implementation; Development, production, or There are data frauds and other serious violations in business activities; import and sales of used medical devices; medical device network trading third-party platforms fail to fulfill the obligations under this regulation; the circumstances are serious; medical devices not established in accordance with the provisions of this regulation Traceability system, to fulfill the responsibility of retroactive medical devices; to refuse or hinder drug inspections.

For 11 kinds of illegal acts including the above-mentioned 6 kinds of behaviors, it stipulates that 'direct personnel are banned from the industry within five years'. Among them, in addition to the above five kinds of behaviors, there are 5 types of illegal acts, and the current “Regulations” are also no individuals. Industry banned by the provisions of the five kinds of illegal activities include: production, management, use of unqualified medical devices; failed to organize or record the product technical requirements for the organization of production, or failed to establish a quality management system and maintain effective operation; Business operations, use expired, invalid, out of medical equipment, or use of unlicensed medical devices; drug supervisors ordered to recall or stop operations, refused to cooperate; commissioned not meet the requirements of enterprises producing medical equipment.

10, Intentional or serious violations of law, fines for individuals, banned from lifelong industry

Add one: If the intentional violation is committed or if there is a gross negligence, or if the circumstances of the illegal act are serious or the nature is bad, or the illegal act causes serious consequences, the person directly in charge of the unit and other persons directly responsible shall be discharged from the unit in the previous year. The income obtained is 30%-1 times fine.

The regulations are added: Holders of medical device marketing licenses for which licenses have been revoked, production and management companies and their directly responsible supervisors and other directly responsible persons shall not apply for medical device licenses or engage in medical device production and business activities within 10 years; Sentenced, lifelong industry banned.

Increase the provisions: Medical device development, production, business units hired by the industry banned, to suspend production or business licenses or revoke permits.

The "Draft Draft" makes it clear that: 'The directly responsible person in charge shall mean the legal representative or principal person in charge, quality management personnel and other personnel responsible for the development, production, management, and use of medical device management.'