Overview

With growing population and increased focus on healthcare, the demand for Medical Devices is consistently growing in Sri Lanka. National Medicines Regulatory Authority (NMRA) is responsible for regulating Medical Devices in the country. It functions under Sri Lankan Ministry of Health (MOH). The process demands the need to operate the device under sample license after which the manufacturer must again approach the NMRA for final approval, which again involves procuring multiple certifications. The agency also requires sample labels and Instructions For Use (IFU) in two locally recognized languages along with English and must be contextually aligned with original label which pose translation challenges.

Freyr provides step-wise guidance with minute tracking of Regulatory process to get the Medical Device market-entry approval in Sri Lanka. For linguistic support, Freyr’s professional experts look over translation errors and corrections. With expertise in end-to-end market authorization process, Freyr provides Regulatory services for successful approval of devices.

Sri Lanka Market Entry for Medical Devices - Process Flow