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.
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:
- 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.