Yesterday, the newly revised “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as “Regulations”) lifted the veil.
The new version of the “Regulations” has 8 chapters and 80 articles. The biggest highlight is that medical devices will be classified and monitored according to the level of risk, raising the entry threshold for high-risk products, and simplifying the entry procedures for low-risk products. At the same time, administrative licenses were reduced, reducing 16 administrative licenses in the original regulations to 9.
The current “Regulations” came into effect on April 1, 2000. Wang Zhenjiang, Director of the Department of Education, Science, Culture, and Health of the Legislative Affairs Office of the State Council stated at a press conference yesterday that there have been some situations that are not suitable for the new situation in the implementation of the current Regulations. First, the classification management system is not perfect, and some measures do not reflect classification. Due to the lack of supervision of high-risk products, the supervision of some low-risk products has not been liberalized, and enterprises report that the burden is heavier. Secondly, the requirements of enterprises in terms of production and operation are too principled and their responsibilities are not specific enough. In addition, there are phenomena such as heavy product approval and light process supervision, and the legal responsibilities are too general, and there is no basis for the investigation and punishment of some illegal acts.
“The new “Regulations” improve the ability of medical device risk management from three aspects: source governance, system governance and legal governance.” said Hu Yinglian, an associate professor at the National School of Administration.
There are many types of medical equipment, huge spans, and complex formats, ranging from nuclear magnetic resonance equipment to tongue depressors, and there are differences in risk. “The characteristics of medical devices determine that the government must implement strict management of medical devices, but it cannot be’one size fits all’. It must be managed by classification, with distinction between leniency and strictness, and’pressurize’ high-risk products and low-risk products. Untie it’.” Wang Zhenjiang said.
Specifically, the new “Regulations” implement classified management of medical devices according to the degree of risk. The first type of medical device products with the lowest risk are changed from registration to filing management; the second type of medical device registration approval authority is delegated to the provincial food and drug regulatory department; 3. Such medical devices have the highest safety risks and are strictly registered and supervised by the State Food and Drug Administration. It is also necessary to strengthen the adverse event monitoring system, the post-marketing re-evaluation system and the recall system. At the same time, the product classification catalogue is required to be adjusted in time according to the production, operation, use of medical devices and the analysis and evaluation of product risk changes; the development and adjustment of the classification catalogue should fully listen to the opinions of production and operation enterprises, users, and industry organizations, and refer to the international Medical device classification practice.
It is worth mentioning that the new “Regulations” not only did not add new licenses, but combined with previous administrative license clearances, the original regulations have reduced the 16 administrative licenses to 9.
In addition to decentralization, the new “Regulations” also focus on strengthening supervision and management during and after the event. Hu Yinglian said that the less pre-licensing is reduced, the more it is necessary to keep up with the supervision during and after the incident, and to effectively manage the matters that the government should manage. The new version of the “Regulations” conducts the entire process of risk control for listed products, and adds a number of management systems such as a medical device adverse event monitoring system, a re-evaluation system, and a recall system. At the same time, it strengthens daily supervision responsibilities, and regulates supervision behaviors such as continued registration and random inspections.
The new “Regulations” set up legal responsibilities according to the seriousness of the violations, and enhance the operability of the clauses. At the same time, adjust the penalty range, increase the types of penalties, and increase the deterrence against serious violations. For example, severe penalties are imposed for unauthorized production and operation of medical devices, and a fine of up to 20 times the value of the goods is stipulated; if an inspection agency issues a false report, the qualification of the agency shall be revoked and included in the “blacklist”. Accept the qualification accreditation application; for those directly responsible for expulsion, it is stipulated that the medical device inspection work shall not be carried out within 10 years.
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