Hong Kong MDD Adds China and Korea to List of Reference Countries

Starting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.  South Korea and China are now added to the list of reference countries along with Australia, Canada, the European Union, Japan and the United States.

Accordingly, the following Guidance Notes and application forms have been updated and are available on the MDD website (www.mdd.gov.hk):

• Guidance Notes: GN-01, GN-02, GN-06
• Application form: MD101, MD102

Products without a reference country approval are required to undergo local conformity assessment by one of the three Conformity Assessment Bodies (CAB) certified by the MDD (ie., BSI Pacific, SGS Hong Kong, or TUV SUD Hong Kong). By allowing manufacturers to show evidence of conformity to the MDD’s assessment requirements by using NMPA or MFDS approval, Chinese and Korean manufacturers will save 12+ months in the registration process. Additionally, products with more than one reference country approval and no reportable adverse events qualify for Expedited Review of its registration application by the MDD. Thus the addition of South Korea and China to the reference country list increases the opportunity product registration applications to qualify for Expedited Review in Hong Kong.

Regional Harmonization in Asia

The recognition of China and Korea as reference countries furthers the regional collaboration in the field of medical device regulation. The expanded program signifies Hong Kong’s commitment to aligning with international, and regional, standards and leveraging the expertise of major competent authorities in the medical device industry. Manufacturers, especially those from Korea and China, seeking approval in Hong Kong can now benefit from a more efficient process, reducing time-to-market and fostering innovation in the rapidly evolving landscape of medical technology.