23
2021
-
03
Revised Regulations on Supervision and Administration of Medical Devices Announced
Premier Li Keqiang recently signed a decree of the State Council to promulgate the revised regulations on the supervision and administration of medical devices (hereinafter referred to as the regulations), which will come into force on June 1, 2021.
Medical devices are directly related to people's lives and health. In recent years, with the rapid development of the medical device industry, the Party Central Committee and the State Council have made a series of major decisions and deployments on the reform of the drug and medical device review and approval system. It is necessary to revise the original regulations accordingly, consolidate the reform results in the form of regulations, and further improve the system level. Promote industry innovation and better meet the people's expectations for high-quality medical devices.
The Regulations implement the system of medical device registrants and filers, and strengthen the main responsibility of enterprises. It is stipulated that registrants and filers shall establish and effectively operate a quality management system, strengthen post-marketing management of products, establish and implement a product traceability and recall system, and be responsible for the safety and effectiveness of medical device development, production, operation and use in accordance with the law.
The Regulations implement the reform measures of "letting go" and encourage the innovation and development of the industry. Incorporate medical device innovation into development priorities, optimize approval and filing procedures, implement implied licensing for clinical trials, shorten the review period, and implement informative filing.
The Regulations improve the regulatory system and improve the effectiveness of supervision. Strengthen the construction of the supervision team, establish a professional professional inspector system, enrich the supervision methods, further clarify the division of responsibilities of the department, and strengthen the supervision and inspection of the use of medical devices.
The Regulations increase penalties and raise the cost of breaking the law. We will implement the requirement of "punishment to people", increase the penalties for illegal units to prohibit entry into the industry and market, and greatly increase the range of fines.
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