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Hong Kong


Market Information

Hong Kong’s healthcare expenditure was 199.9 billion Hong Kong dollars during the fiscal year 2020/21, accounting for over seven percent of the region's gross domestic product (GDP). Over the last decade, Hong Kong's healthcare spending demonstrated substantial growth, escalating from 84.4 billion Hong Kong dollars in 2008/09 to nearly 200 billion Hong Kong dollars in the latest recorded period.

Market Trend: All Singaporeans have basic medical insurance in the form of MediShield Life. Another 69% have the Integrated Plan on top of the basic insurance.


Hong Kong’s medical equipment market anticipated revenue is projected to demonstrate an annual growth rate (CAGR 2024-2028) of 7.01%, leading to a market size of US$1,006.00 million by the year 2028.


The inception of the Medical Device Division (MDD), formerly recognized as the Medical Device Control Office (MDCO), took place in July 2004. The MDD holds accountability for executing the Medical Device Administrative Control System (MDACS) and formulating a sustained statutory regulatory structure for medical devices.

Market Info

Medical Device Regulation

Medical Device Division (MDD), under the DOH.

Classification, Fees, Timeline
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Product Registration Routes

Class I

similar to Class I and A in EU and IMDRF respectively

Class II

similar to Class IIa and B in EU and IMDRF respectively

Class III

similar to Class IIb in EU and IMDRF respectively

Class IV

similar to Class III or D in EU and IMDRF respectively

Useful Information

Validity of License: 5 years.


License transfer: A transfer application is required. 

Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.



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