ASEAN
CAMBODIA
Market Information
Cambodia’s healthcare expenditure accounted for 485 million USD in 2019.
Market Trend: 30% of the population benefits from health insurance.
Cambodia’s medical equipment market is anticipated to witness a steady annual growth rate of 8.40% from 2023 to 2028 (CAGR 2023-2028), resulting in a market volume of US$128,800.00k by 2028.
In Cambodia, the oversight of medical devices falls under the jurisdiction of the Department of Drugs and Food (DDF) operating within the Ministry of Health. The primary regulatory framework governing medical devices is outlined in Prakas No. 1258, dated November 8, 2012, which details the procedures for the registration of medical devices, henceforth referred to as 'Prakas 1258'.
Medical Device Regulation
Department of Drugs and Food (DDF), 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: Reregistration is needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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