Legal analysis: "Measures for the Supervision and Administration of Medical Device Production" is a method in order to strengthen the supervision and administration of the production of medical devices, standardize the production activities of medical devices, and ensure the safety and effectiveness of medical devices, according to the "Regulations for the Supervision and Administration of Medical Devices".
On March 10, 2022, the State Market Supervision and Administration Order No. 53 published the "Measures for the Supervision and Administration of Medical Device Production", which came into effect on May 1, 2022.
Medical device safety and people's health are closely related to the strict implementation of the "four most stringent" requirements, the implementation of the "supervision and management of medical devices regulations", the full implementation of the medical device registrant filer system, optimize the administrative licensing process, strengthen the supervision and inspection measures, improve supervision and inspection means, and strengthen the main responsibility of enterprises. The main responsibility of enterprises, and further increase the penalty for violations.
Strengthen the quality and safety risk control. Combined with the actual supervision work to further refine and improve the medical device production and management classification management and risk control, have cause to check the requirements. Strengthen the quality and safety risk control, classification of clear production and operation of supervision and inspection of the focus of the medical device registrants, filers and business enterprises specifically to provide transportation, storage services, clear quality responsibility and management requirements. At the same time, clear drug regulatory authorities should be based on supervision and inspection, product sampling, adverse event monitoring, complaints and reports, administrative penalties, etc., and regularly carry out risk consultation and judgment, and do a good job of medical device quality and safety risks and prevention, control and disposal work.
Legal basis: "supervision and management of medical device production"
Article 1 In order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the formulation of these measures.
Second, in the Chinese people *** and the country engaged in the production of medical devices and its supervision and management, shall comply with these measures.
Article 3 engaged in the production of medical devices, shall comply with laws, regulations, rules, mandatory standards and quality management standards for the production of medical devices, to ensure that the whole process of medical device production information is true, accurate, complete and traceable.
Medical device registrants, filers of listed medical devices are responsible for the safety and effectiveness.
Article IV According to the degree of risk of medical devices, medical device production implementation of classification management.
Engaged in the second, third class medical device production activities, should be approved by the local provincial, autonomous regions and municipalities directly under the Central Drug Administration, according to law to obtain a medical device production license; engaged in the production of Class I medical devices, should be located in the municipal drug supervision and management department responsible for the production of medical devices for the record.