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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:

  1. “Certificate of Listing” of medical devices under the Medical Device Administrative Control System (MDACS) with legal manufacturers in Hong Kong;
  2. “Certificate to CFDA” (for devices outside the scope of the MDACS).

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:

Device Class Certificate Recognized by the CFDAApplication Form for the CertificateApplication Guidance
Class II/III/IV general medical devices and Class D IVD medical devicesCertificate of ListingMD-C2&3&4, MD-IVD [GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices
[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices
Class I general medical devices and Class A/B/C IVD medical devicesCertificate to CFDAMD-CFDA Application guidance for the “Certificate to CFDA” as below

Application guidance for the “Certificate to CFDA”:

Local manufacturers can apply for the “Certificate to CFDA” from the MDCO with the following conditions:

  1. The manufacturers are included in the list of local manufacturers under the MDACS (Please refer to “[GN-08] Guidance Notes for Listing of Local Manufacturers” for details of application);
  2. The concerned devices are manufactured by the listed local manufacturers; and
  3. The concerned devices have been sold to local healthcare facilities within two years counting from the application date of the “Certificate to CFDA”.

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.

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Last Revision Date : 29 October 2015