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. Following a series of scandals in 2008, the regulatory body was put under the supervision of the Ministry of Health (MoH). The NMPA was restructured in March 2013 and elevated to a ministerial-level agency; April 2018 restructuring removed its oversight of food safety. Further restructuring is expected in 2019.
The National Medical Products Administration is part of the State Administration for Market Supervision or SAMS. 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.
The NMPA departments dealing with medical devices are:
- Department of Medical Device Registration, responsible for pre-market approvals
- Department of Medical Device Supervision, responsible for post-market supervision
A list of NMPA regulations can be found here on our website.
- Website: http://eng.sfda.gov.cn/