Understanding of the medical devices competent authorities in China

In China, there are several authorities involved in the medical device supervision and administration, the each administrative authority is responsible for controlling the risk raised from the relevant stage of the product supply chain.

China competent authorities	Supervised and administrated Items
China Food and Drug Administration (CFDA) and the provincial food and drug administration bureau.	Medical device registration and evaluation, manufacturing and distributing license, quality assurance.
The National Health and Family Planning Commission of PRC (NHFPC)	Safety and hygiene management of medical devices used in the medical institutes.
General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the provincial Entry-Exit Inspection and Quarantine Bureau (CIQ)	Certification and accreditation of quality system, and supervision on the import or export activities of medical devices with its package

The China Food and Drug Administration (CFDA) (Chinese:国家食品药品监督管理总局) is in the highest level of administration authorities, which is in charge of regulation and comprehensive supervision of medical devices in China. CFDA was founded on the basis of the former State Food and Drug Administration (SFDA). It was in March 2013, SFDA was rebranded and restructured as CFDA. CFDA possess two significant subordinate institutes: CMDE (Center for Medical Device Evaluation) and CAS (Center for Administration Service), which are in charge of the technically review, evaluation and approval of the medical device registration.
The National Health and Family Planning Commission of PRC (NHPFC, former MOH) is the legal administration authority in charge of comprehensive supervision on the safety and hygiene management of medical devices used in the medical institutes.
The provincial Entry-Exit Inspection and Quarantine Bureau (CIQ) governed by the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) is the legal authorities in charge of certification and accreditation of quality system, and supervision on the import or export activities of medical devices with its package.