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 Freyr Expertise Medical Device Classification Sri Lankan Local Authorized Representation Support in Procuring Sample Import License Post-Market Surveillance Summary S.No Regulatory Parameter Sri Lanka 1 Regulatory Authority National Medicines Regulatory Authority (NMRA) 2 Regulation National Medicines Regulatory Authority (NMRA) Act, No. 5 of 2015 3 Risk Classification Not Applicable 4 Regulatory Pathway Registration + Import License 5 Authorized Representative Marketing Authorization Holder Required 6 Fee payable $1,600* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data Medical Devices Regulatory (MDR) Division 9 Validity of License 5 Years 10 Labelling Requirements Section 77 of NMRA Act, No. 5 of 2015 11 Submission format Paper 12 Final Outcome Registration + Import License 13 Timelines 9 - 12 Months 14 Language English, Sinhala & Tamil *The price is as per records at the time of documentation and is subject to change.