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AMERICAS
CANADA
Market Information
Canada’s healthcare expenditure was projected to hit $344 billion in 2023, the overall healthcare expenditure in Canada is estimated at $8,740 per Canadian. This is expected to account for 12.1% of Canada's gross domestic product (GDP) in the same year.
Market Trend: Approximately 65 to 75 percent of Canadians have some form of supplementary health insurance.
Canada’s medical equipment market revenue is expected to show an annual growth rate (CAGR 2024-2028) of 6.36%, resulting in a market volume of US$14.10bn 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
Canadian Medical Device Regulation (CMDR), under the MOH.
Classification, Fees, Timeline
Product Registration Routes
Class I, II, III, IV
Useful Information
Validity of License: Needs to be renewed every year.
License transfer: Not applicable.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
