¡ö Department of Medical Devices
¡õ Office for Acceptance
¡õ Division for Standards
¡õ Division of Product Registration
¡õ Division for Product Safety
¡õSecretariat of Standardization
¡ö Center for Technology Evaluation and Testing
¡ö Medical Device Divisions in Bureaus of various Provinces
¡ö China Quality Certification Center for Medical Devices
¡ö Standardization Committee
Department of Medical Devices of State Food and Drug Administration
Functions:
1. Draft, amend, and promulgate with authorization official standards for medical devices, invitro diagnostic reagents, medical dressings, and formulate the lists for classified product administration;
2.Registration of imported medical devices, clinical trial sites;
3.Review and issue product registration certificates and manufacture licenses for medical device products;
4.Examination and approval of medical device advertisement.
Under it are set up following main divisions and offices:
1.Office for Acceptance;
2.Division for Standards;
3.Division for Product Registration;
4.Division for Product Safety;
5.Division for Standardization.