ISO 13485 & SFDA QMS Requirements
Overview
The SFDA requires all manufacturers, importers, distributors, and Authorized Representatives operating in the Saudi medical device market to implement and maintain a Quality Management System (QMS) certified to ISO 13485:2016 or the Saudi-specific standard SFDA.MD/GSO ISO 13485.
QMS certification is both a prerequisite for MDMA and an ongoing MDEL maintenance requirement.
The Saudi QMS standard: SFDA.MD/GSO ISO 13485
Saudi Arabia has adopted a national version of ISO 13485 through the Gulf Standards Organisation (GSO): SFDA.MD/GSO ISO 13485. This is substantially identical to ISO 13485:2016 but may include Saudi-specific additions or modifications. The SFDA accepts certification to:
- SFDA.MD/GSO ISO 13485 (preferred)
- ISO 13485:2016 from an IAF-accredited certification body
Who must hold QMS certification?
| Entity | QMS requirement |
|---|---|
| Manufacturer (foreign) | ISO 13485 certification from CAB or IAF-accredited CB |
| Authorized Representative | ISO 13485 (for AR regulatory management activities) |
| Importer | ISO 13485 |
| Distributor | ISO 13485 |
Further reading
- MDS-REQ 3 — QMS requirements
- SFDA Conformity Assessment Bodies (CABs)
- Inspections and Audits