On March 10, 2022, Order No.53 of the State Administration of Market Supervision promulgated the Measures for the Supervision and Administration of Medical Device Production, which will take effect on May 1 0, 2022.
The safety of medical devices is closely related to people's health. It is necessary to strictly implement the "four strictest" requirements, implement the Regulations on the Supervision and Administration of Medical Devices, comprehensively implement the system of medical device registrants and filers, optimize the administrative licensing process, strengthen supervision and inspection measures, improve the means of supervision and inspection, consolidate the main responsibility of enterprises, and further increase the punishment for illegal acts.
Strengthen quality and safety risk management and control. Combined with the actual supervision work, the requirements of hierarchical management, risk control and causality test of medical device production and operation have been further refined and improved. Strengthen quality and safety risk control, classify and clarify the key points of supervision and inspection of production and operation, and clarify the quality responsibility and management requirements for providing transportation and storage services for medical device registrants, filers and operating enterprises. At the same time, it is clear that the drug regulatory authorities should regularly carry out risk consultation and judgment according to supervision and inspection, product sampling, adverse event monitoring, complaints and reports, and administrative penalties. , and do a good job in the investigation and prevention and control of medical device quality and safety hazards.
Legal basis: Measures for the Supervision and Administration of Medical Device Production
Article 1 In order to strengthen the supervision and administration of medical device production, standardize the production activities of medical devices and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 The production activities of medical devices and their supervision and management within the territory of People's Republic of China (PRC) shall abide by these Measures.
Article 3 Those engaged in the production of medical devices shall abide by the laws, regulations, rules, mandatory standards and quality management norms of medical device production, and ensure the truthfulness, accuracy, completeness and traceability of the information in the whole process of medical device production.
Medical device registrants and filers are responsible for the safety and effectiveness of medical devices in the market.
Article 4 According to the risk degree of medical devices, the production of medical devices shall be subject to classified management.
Engaged in the production of Class II and Class III medical devices shall be approved by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located, and obtain the Medical Device Production License according to law; Engaged in the production of medical devices of category I, it shall go through the medical device production record with the local municipal drug supervision and administration department.