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 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.