Jul 15, 2018
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.
According 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:
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.