Notice to local manufacturers in applying for medical device registration in Mainland China
Please be informed that the China Food and Drug Administration (CFDA) now recognizes the following two certificates issued by the Medical Device Control Office (MDCO) as equivalent to the “marketing approval” obtained from the place of origin of the device:
Local manufacturers may use “Certificate of Listing” or “Certificate to CFDA” as one of the supporting documents in applying for medical device registration in Mainland China.
The scope of MDACS includes listing of Class II/III/IV general medical devices and Class D in vitro diagnostic (IVD) medical devices. MDCO will issue the “Certificate to CFDA” to medical devices which are not entitled to be listed under the MDACS. The application details of the certificates are stated below:
Application guidance for the “Certificate to CFDA”:
Local manufacturers can apply for the “Certificate to CFDA” from the MDCO with the following conditions:
An application for the “Certificate to CFDA” must be made on the application form (MD-CFDA), which can be downloaded here. The original copy of the completed application form together with the supporting documents must be submitted, by hand or by mail, to the MDCO. Applicants are encouraged to provide softcopies of supporting documents in CD-ROM format as far as possible.