How to register a medical device in Hong Kong

This video gives medical device manufacturers a clear, step-by-step look at how to register their products in Hong Kong under the Medical Device Administrative Control System (MDACS), managed by the Department of Health’s Medical Device Division (MDD). While Hong Kong’s system is voluntary, early registration is highly encouraged and often preferred by healthcare providers. For foreign manufacturers without a local presence, appointing a Local Responsible Person (LRP) is essential for market access.

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Topics covered in this video include:

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• Hong Kong’s medical device market trends and growth drivers
• MDD’s voluntary MDACS registration framework and risk-based classification system
• Which device classes benefit most from registration
• The mandatory role of the Local Responsible Person (LRP) for foreign manufacturers
• How Pure Global streamlines Hong Kong medical device registration and post-market compliance

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Hong Kong offers substantial opportunities for medtech companies. With a population of over 7 million and healthcare spending on the rise, the market is projected to reach USD $1.11 billion by 2029, growing at 6.73% annually. The in vitro diagnostic (IVD) segment is also expanding, expected to hit USD $33 million by 2029. Demand is being fueled by increased healthcare investment and a rapidly aging population—20% aged 65+ in 2021, projected to reach 32% by 2041.

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The MDACS framework uses a four-tier, risk-based device classification system (Class A to Class D), with higher-risk devices (Class II and above for medical devices, and Class D for IVDs) receiving particular scrutiny. Registration under MDACS, though not legally required, provides smoother market entry, builds trust with healthcare institutions, and can be a competitive differentiator.

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For manufacturers outside Hong Kong, the LRP acts as your official in-country representative, managing the full regulatory lifecycle. This includes identifying the correct classification, preparing and submitting the technical dossier to the MDD, liaising with regulators, and ensuring ongoing compliance through post-market surveillance. Without an LRP, it is not possible to complete registration or maintain compliance in Hong Kong.

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Ready to learn more?
Pure Global’s Hong Kong-based regulatory team combines local expertise with global reach, offering one streamlined process for Hong Kong and 30+ other markets. Our AI-enabled tools flag documentation gaps early, cutting submission time and reducing risk. From classification strategy to post-market duties, we help you enter and thrive in Hong Kong’s growing medtech sector. Learn more about medical device registration in Hong Kong.

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