NMPA News

“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)”

In order to fully implement the main responsibility for the quality and safety of medical device registrants, prevent and control the hidden risks of medical device entrusted production, and strengthen the supervision of medical device entrusted production, the State Food and Drug Administration organized the drafting of “Opinions on Further Strengthening the Supervision of Medical …

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Non-Conformity of NMPA Unannounced Inspections

Recently, the State Food and Drug Administration organized an inspection team to conduct unannounced inspections on three companies including Tianjin Soma Technology Co., Ltd., and found defects in the quality management system of the companies. Details are as follows:  1. Tianjin Soma Technology Co., Ltd. (1) Institutions and personnel Insufficient ability of inspectors to perform …

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Guangdong Province held a research symposium on the construction of the medical device database

Event On June 20th, in order to comprehensively implement the Party Central Committee and Provincial Party Committee’s deployment requirements for carrying out thematic education on studying and implementing Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, as well as the Party Central Committee’s decision to promote investigation and research throughout the …

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