Hong Kong Adds Singapore to List of Reference Countries

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) on a regular basis, accepts the marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS. Singapore’s HSA is now added to the list of reference countries along with:

– China (National Medical Products Administration)
– Australia (The Therapeutic Goods Administration)
– Canada (Health Canada)
– Member countries of European Union that have implemented relevant EU directives or regulations and a copy of the EC Declaration of Conformity
– Japan (Ministry of Health, Labour and Welfare)
– Singapore (Health Sciences Authority)
– South Korea (Ministry of Food and Drug Safety)
– United States of America (U.S. Food and Drug Administration)

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).

Expedited Review

By allowing manufacturers to show evidence of conformity to the MDD’s assessment requirements by using HSA approval, Singaporean 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 Singapore to the reference country list enables product registration applications to qualify for Expedited Review in Hong Kong.

The Expedited Approval Scheme provides qualifying Class II, III, and IV applications with a quicker review. To qualify, products will need to have 2 Reference Country approvals, no serious adverse events, and no ongoing adverse events. Reference Countries include the US, Canada, Europe, Australia, Japan, China, Korea and Singapore. The MDD’s formal guidance can be found here under GN-02. Official review times have not been provided yet but the MDD assures manufacturers that the applications will receive a more expedited review.

Regional Harmonization in Asia

The recognition of Singapore as a reference country 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 Singapore and since January 2024, China and Korea,  can now benefit from a more efficient approval-seeking process, reducing time-to-market and fostering innovation in the rapidly evolving landscape of medical technology.