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China FDA Eases Country-of-Origin Requirements for Hong Kong-based Medical Device Registrants

Regulatory Updates | Medical Devices

The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements.

China CFDA accepting Hong Kong MDCO medical device certificates for country of origin requirementsAccording to the MDCO,  CFDA now accepts two types of certificates issued to Hong Kong-based manufactures applying for market authorization in China as evidence of home-market approval:

  • Certificates of Listing, issued to medical devices falling under Hong Kong’s Medical Device Administrative Control System (MDACS); Class II, III and IV medical devices as well as Class D IVDs are covered by MDACS.
  • Certificates to CFDA, covering devices manufactured in Hong Kong but falling outside the scope of MDACS, including Class I medical devices and Class A, B and C IVDs.

Thus, Hong Kong-based manufacturers seeking market entry into China may now utilize Certificates of Listing or Certificates to CFDA as supporting documentation in their registration applications.

Additional Hong Kong and Chinese medical device regulatory resources:

  • China CFDA medical device registration consulting
  • Hong Kong MDCO medical device registration consulting

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