CFDA publishes medical device clinical examination procedures and key points (with full text)
Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, Food and Drug Administration of Xinjiang Production and Construction Corps:
To enhance the ability to identify risk medical devices regulators to enhance the production level of risk prevention and control regulation of medical devices, according to "Supervision and Regulation of Medical Devices" (State Council Decree No. 650), "Production Supervision and Administration of Medical Devices" (Food and Drug Administration of Work Order No. 7), "Medical Device Manufacturing Quality Management Regulations" (General Administration of Food and Drug Administration Announcement No. 64 of 2014) and its supporting documents, the Food and Drug Administration has organized the development of 25 kinds of medical devices such as single-use sterile syringes. The list of production link risks and inspection points (hereinafter referred to as "risk list and inspection points") is now issued.
According to the "Medical Device Production Quality Management Regulations" and related documents, combined with the typical characteristics of different varieties and typical production processes, the risk links, risk points and corresponding inspection points of medical device manufacturers are carried out. The carding, focusing on procurement, production control, quality control and other aspects that are closely related to the product realization process and relatively high risk. If the "Medical Device Production Quality Management Regulations" and its related supporting documents have been specified in more detail, the "Risk List and Checkpoints" are no longer covered.
The "List of Risks and Checkpoints" is mainly used by supervisors of food and drug supervision and administration departments at all levels to supervise and inspect relevant medical device manufacturers, and cooperate with the guidelines for on-site inspection of the "Medical Device Manufacturing Quality Management Regulations" as guidelines. Other types of Inspection can also be used as reference.
Accessories: Risk list and inspection points for 25 medical devices such as single-use sterile syringes
Food and Drug Administration, March 31, 2016
Risk list and checkpoints for production of 25 medical devices such as single-use sterile syringes.doc
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