Overview Healthcare in Kingdom of Saudi Arabia (KSA) is recognized as a prime sector by government of KSA, and there is a growing need for Medical Devices in the country. Saudi Food and Drug Authority regulates the Medical Devices in Saudi, reporting to the Council of Ministers. But Saudi has special regulations in place influenced by cultural inclinations. The classification is broader than most others, with sub-classes (Class I, IIa, IIb, and III). Linguistic barriers, rigorous scrutiny and less cooperation from the agency are the major bottlenecks to further proceed for device approval. Freyr navigates device manufacturers for full-scale device compliance. Freyr assists in appointing Saudi Authorized Representative, document compilation and provides linguistic support to deal with the agency. Freyr also liaises with the SFDA to expedite the approval process. Saudi Arabia Market Entry for Medical Devices - Process Flow Freyr Expertise Medical Device Classification Saudi Authorized Agent Representation Dossier/Document Compilation Post-Market Surveillance Summary S.No Regulatory Parameter KSA 1 Regulatory Authority Saudi Food & Drug Administration (SFDA) 2 Regulation Interim Regulation Decree number 1-8-1429, 2008 3 Risk Classification (As per GHTF reference country) Class I Class I Class IIa Class II Class IIb Class III Class III Class IV 4 Regulatory Pathway Marketing Authorization 5 Authorized Representative Saudi authorized representative is required 6 Fee payable Administrative Fees $300* Reduced Fees $1,350* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data Conformity Assessment Body (CAB) 9 Validity of License Class I 3 years Rest Depends on CE Mark 10 Labelling Requirements Article 18 of Interim Regulation 11 Submission format Electronic application @ MDMA 12 Final Outcome Marketing Authorization 13 Timelines 1 - 2 Months 14 Language English & Arabic *The price is as per records at the time of documentation and is subject to change.