Medical Devices & Equipment

Medical Devices & Equipment

Miqyass supports manufacturers, importers, and brand owners in the medical devices and healthcare sector by providing specialized regulatory and compliance consultancy for the Saudi and GCC markets.

We assist clients in navigating SFDA medical device requirements, product classification, registration, authorization, and post-market compliance obligations with clarity and confidence. Our team supports companies throughout the regulatory journey, from market entry planning to maintaining ongoing compliance within the Saudi healthcare ecosystem.

Our services include regulatory classification, Medical Device Marketing Authorization (MDMA) support, technical documentation review, conformity assessment guidance, quality management system support, testing and certification coordination where applicable, and communication with relevant regulatory authorities. Miqyass works closely with clients to ensure regulatory accuracy, minimize approval risks, and facilitate successful market access.