The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices. When it was given jurisdiction over food in 2003, it was renamed the State Food and Drug Administration and reported to the State Council. In 2018, restructuring removed its oversight of food safety and it is now part of the State Administration for Market Regulation (SAMR). Its responsibilities include drafting laws and regulations for drugs, medical devices, and cosmetics, as well as establishing medical device standards and classification systems. For a full list of responsibilities, please consult this entry on the NMPA website (in Chinese).
The NMPA departments dealing with medical devices are:
A list of NMPA regulations can be found here on our website.
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
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