ASIA
Sri Lanka
Market Information
Sri Lanka’s healthcare expenditure about 2-3% of GDP, relies heavily on government funding for primary care and preventive services, achieving notable health outcomes despite limited resources. However, out-of-pocket expenses remain high, as citizens often pay directly for medications and specialized care, with private healthcare spending steadily increasing due to gaps in public coverage.
Market Trend: In 2016, Sri Lanka introduced reforms to strengthen its healthcare system, with a focus on expanding access to services and improving quality. These reforms have led to a notable increase in the number of individuals covered by public health insurance, rising from around 60 percent in 2010 to approximately 80 percent by 2023. Alongside this, there has been a gradual rise in the adoption of private health insurance, driven by growing demand for specialized services and private healthcare facilities, contributing to the expansion of the overall medical market in the country.
Sri Lanka's medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 6.2%, reaching a market volume of approximately US$1.2 billion by 2028. This growth is driven by increased demand for advanced medical technologies, expanding healthcare infrastructure, and greater private sector investment in modern medical devices.
The National Medicines Regulatory Authority (NMRA) is Sri Lanka's primary regulatory body under the Ministry of Health, holding the highest authority in ensuring medical safety for medicines, medical devices, cosmetics, and healthcare products.
Medical Device Regulation
National Medicines Regulatory Authority (NMRA), under the MOH.
Classification, Fees, Timeline
Product Registration Routes
Medical Devices: Listed Device/I/IIa/IIb/III
IVDs: A/B/C/D
Useful Information
Validity of License: 1year
License transfer: Transferring registration certificate from one MAH to another MAH is possible and application to NMRA 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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