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MIDDLE EAST
SAUDI ARABIA
Global > Middle East >
Saudi Arabia
Market Information
Saudi Arabia’s healthcare expenditure was 16.96 percent of its budget in 2023, amounting to $50.4 billion, will be allocated to healthcare and social development, making it the second largest expenditure after education.
Market Trend: The Health Insurance market's gross written premium is anticipated to achieve a value of US$4.43 billion by the year 2024.
Saudi Arabia’s medical equipment market is expected to reach US$0.51 billion by 2024, with an anticipated compound annual growth rate (CAGR) of 2.82% from 2024 to 2028.
The regulation of medical devices and in vitro diagnostics (IVDs) in Saudi Arabia is overseen by the Saudi Food and Drug Authority (SFDA). To market medical devices, including IVDs, in the Kingdom of Saudi Arabia (KSA), obtaining a Medical Device Market Authorization (MDMA) from the SFDA is mandatory.
Medical Device Regulation
Saudi Food and Drug Authority (SFDA), under the MOH.
Classification, Fees, Timeline
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Product Registration Routes
Class A, B, C, D
Useful Information
Validity of License: 3 years.
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.
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