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ASIA
HONG KONG
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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: Hong Kong offers subsidized public healthcare for all residents, with 50% opting for private insurance under the VHIS for added coverage.
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.
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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