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The provincial bureau deploys the daily

In order to effectively strengthen the supervision of medical device manufacturers, continuously innovate supervision methods, strengthen risk management, and promote enterprises to improve their awareness of production according to law, the provincial bureau issued a notice to make arrangements for the daily supervision and inspection and credit rating of medical device manufacturers in the province. The notice requires that, first, we must adhere to the principle of “highlighting key points, controlling risks, focusing on curing the root cause, and seeking practical results”, and focus on organizing special quality system projects for manufacturers of animal-derived medical devices, endovascular stents and pipelines with high-risk products Inspection; Second, we must carefully analyze the situation of production enterprises in the region, improve emergency response capabilities, and properly handle various medical device safety emergencies that may occur in a timely manner; third, continue to implement the quality authorized person system for production enterprises, and gradually expand pilot projects based on specific local conditions Scope; Fourth, we must further improve the daily supervision files of medical device manufacturers, establish a sound information database, and gradually realize real-time dynamic supervision; Fifth, we must check and promote enterprises to strengthen risk management, product quality listing tracking and adverse event monitoring, and promote enterprises to improve emergency response capabilities And risk management level.

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