The medical device industry in Asia is experiencing phenomenal growth, driven by factors like an aging population, increasing healthcare expenditure, and technological advancements. However, navigating the complex regulatory landscape across different Asian countries can be a significant hurdle for manufacturers seeking to bring their products to market. Working together to simplify regulations across Asia can speed up the approval process for new medical devices. This means patients get these innovative tools faster, and companies can bring their products to market quicker.


Regional Harmonization in Asia

Regional harmonization in the medical device industry refers to efforts by regulatory bodies in different countries to establish a more consistent set of regulations and requirements. This fosters greater efficiency for manufacturers seeking approval in multiple markets and helps ensure patients have access to safe and effective medical devices faster.


A Case for Streamlined Regulations

Streamlined regulations can significantly benefit this growth by:

  • Reducing Time to Market: Manufacturers no longer need to undergo lengthy and duplicative approval processes in each country they wish to enter. This expedites patient access to potentially life-saving medical devices.
  • Lowering Regulatory Costs: Harmonization reduces the need for manufacturers to maintain separate regulatory teams and adapt their products to meet specific country requirements. These cost savings can be reinvested in research and development, leading to further innovation.
  • Ensuring Patient Safety: Harmonized regulations built on robust risk-based frameworks promote a high standard of safety for medical devices across the region.

Hong Kong MDD is Streamlining Medical Device Approvals

The Hong Kong Medical Device Division (MDD), established in 2004, is responsible for implementing the Medical Device Administrative Control System (MDACS). MDACS ensures the safety, efficacy, and quality of medical devices available in Hong Kong.

The concept of "reference countries" plays a vital role in streamlining medical device approvals. Countries like Hong Kong recognize regulatory approvals granted by designated reference countries with robust regulatory frameworks. This allows manufacturers to leverage their existing approvals from these reference countries to expedite the approval process in Hong Kong.


Singapore HSA is Now Recognized as a Reference Country by Hong Kong MDD

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) Manufacturers with existing HSA approvals for their medical devices can leverage this change to gain faster market access in Hong Kong. The process of submitting technical documentation and undergoing separate clinical evaluations in Hong Kong can be significantly simplified. This translates to reduced costs, faster market entry, and increased efficiency.


Reference Countries: A Growing List

In addition to Singapore, Hong Kong MDD recognizes approvals from other countries with well-established regulatory frameworks, including:

  • China (National Medical Products Administration)
  • Australia (The Therapeutic Goods Administration)
  • Canada (Health Canada)
  • Member countries of the European Union
  • Japan (Ministry of Health, Labour and Welfare)
  • South Korea (Ministry of Food and Drug Safety)
  • United States of America (U.S. Food and Drug Administration)

This growing list of reference countries signifies a positive trend towards greater regulatory convergence in Asia, ultimately benefiting the entire medical device ecosystem.


Key Takeaways

The recognition of Singapore's HSA as a reference country by the Hong Kong MDD is a welcome step towards streamlining medical device approvals in Hong Kong market.


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Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, connect with us today here to unlock your medical device potential in Asia-Pacific region.




Announcement of the acceptance of marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore

Industrial Newsletter Email from HSA