The Kingdom of Saudi Arabia published guidance regarding licensing medical device establishments in July 2022 under the government regulatory agency, The Saudi Food and Drug Authority (SFDA). The guidance is to provide a clear understanding and specify medical device establishment requirements without amending the nation’s laws and regulations. As SFDA refers to Article 6 of the Medical Devices Law, an establishment should obtain the authorized license before practicing any activities subject to the Medical Device Law.
SFDA has been authorized by the government to be responsible for verifying the application documents and ensuring all the requirements are completed. Besides, SFDA is responsible to do an inspection of the establishment in order to ensure it complies with the requirements. SFDA may reject the license requests if the establishments do not meet the specific requirements, while for the establishments that meet up the requirements, the license will be issued by SFDA and the validity is for one year. SFDA has the legal right to do periodic supervision and inspection of establishments and take action for any establishments that fail to comply with the law. Lastly, SFDA also has to publish all the licensed establishments on the website for public view.
Variants of parties are included in the implementation of medical devices establishments’ requirements for instance, manufacturers, authorized representatives, importers, distributors, optical establishments, warehouses and clinical trials verification establishments and a few others. However, pharmacies, sub-sale establishments and prosthetics or dental or similar laboratories are excluded from the requirements. Apart from general requirements that needed to be fulfilled, each party also has its specific requirements and obligations that vary from each other that have to comply with.
Among the general requirements are establishments have to provide evidence of all requirements and legal procedures compliance before applying for licensing. Establishments also must have a legal body to be legally responsible for any activities and decisions and must be in compliance with KSA’s law and regulations. Any manufacturers, importers or distributors for Category A and Category B must obtain a quality management system (QMS) from SFDA’s legal Conformity Assessment Bodies (CAB) for medical devices. Meanwhile, for Category C and Category D, the parties should submit an inspection SFDA report and ensure all the QMS are in accordance with the SFDA standard, ISO 13485.
Source: SFDA
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