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.
为了获得澳大利亚市场准入,医疗器械和体外诊断(IVD)器械制造商需要将他们的产品列入由药品管理局(TGA)监管的澳大利亚医疗用品登记表(ARTG)。
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