This document discusses regulatory requirements for medical equipment in Sri Lanka. It provides an overview of Sri Lanka's healthcare system, including demographics, disease patterns, healthcare spending, and regulatory authorities. Key points covered include: - Sri Lanka has a mixed public-private healthcare system and is experiencing an aging population and epidemiological transition to non-communicable diseases. - The medical equipment market in Sri Lanka is growing but still dependent on imports, with total market size reaching $40 million in 2008. - Medical devices must be registered with the Cosmetic Devices and Drugs Authority and the Atomic Energy Authority, which is a multi-step process requiring documents and fees. - Regulations are generally less stringent than in India, with