Saudi medical-device licensing puts the factory team in the application
Who will be the technical director and quality manager of your Saudi medical-device factory?
Those roles appear in SFDA's manufacturer-licensing procedure. The application calls for their academic qualifications and experience certificates, if any, alongside a copy of the ISO 13485 quality-management-system certificate.
For a foreign manufacturer moving from imported devices to Saudi production, that is a useful question to raise when selecting a local partner. Ask who will hold those responsibilities in the proposed manufacturing establishment, and which qualifications will support the application.
SFDA's guide also asks for the industrial licence and location-related documents. It treats manufacturing as a distinct licensed activity, with its own submission requirements.
A partner with a distribution business still needs to show how the proposed factory will meet these manufacturing requirements.
Agree early who will prepare the quality-system evidence and the personnel documents. Use that division of responsibilities to schedule the licensing submission before production starts.
Sources
- SFDA — Guidance on the procedures for licensing of medical devices and supplies establishmentsGuide landing page dated 22 January 2024. Pages 8-9 list the manufacturer requirements, including ISO 13485 and the two personnel roles, with qualifications and experience certificates "if any". It sets no nationality, degree subject or years of experience, and an establishment licence is not a product marketing authorisation. Accessed 24 September 2026.