ASEAN
SINGAPORE
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Market Information
Singapore’s healthcare expenditure was estimated to be $13.2 billion in 2020 and is expected to grow to $36 billion in 2029.
Market Trend: About 2.9 million people, approximately 71% of the population, are covered by health insurance.
Singapore’s medical equipment market is expected to display an annual growth rate (CAGR 2023-2028) of 6.48%, leading to a market volume of 1.12 million US by 2028.
The Health Sciences Authority (HSA) was formed in 2001 when voluntary registration was introduced. HSA regulates medical devices including IVDs under the Health Products Act 2007. All products are approved by the Medical Device Branch of HSA before it can be supplied in Singapore.
Medical Device Regulation
Health Science Authority (HSA), under the MOH.
Regulation of medical devices done under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.
Classification, Fees, Timeline
Product Registration Routes
Class A (Product registration not required)
Declare in the Class A exemption list (under manufacturer/importer license)
Class B, C, D (Online submission to MEDICS)
Determine grouping of medical device
•Immediate route
•Expedited route
•Abridged route
•Full route
Priority Review Scheme 1
Priority Review Scheme 2
Useful Information
Validity of License: 12 months (Renewable through GIRO)
License transfer: Change of Registration application needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
