SFDA Conformity Assessment Bodies (CABs)

What is a CAB?

An SFDA Conformity Assessment Body (CAB) is a certification body accredited by the SFDA to audit and certify QMS under ISO 13485 (SFDA.MD/GSO ISO 13485) for medical device establishments in Saudi Arabia.

CAB vs. IAF-accredited CB

Certification body	Acceptable for...
SFDA-accredited CAB	Class A and B devices (mandatory); Class C and D (acceptable)
IAF-accredited CB	Class A and B devices (acceptable alternative)

For Class C and D devices, the SFDA may additionally require an on-site SFDA inspection or conduct a direct audit of manufacturing facilities regardless of whether a CAB or IAF-accredited certification body has already certified the QMS.

Finding an approved CAB

The SFDA publishes a list of currently accredited CABs on the SFDA website (medical devices section). Always verify that your chosen CAB's accreditation scope covers your device type before engaging them for certification.

The CAB certification process

1. Select an SFDA-accredited CAB with the appropriate scope
2. Submit QMS documentation for desk review
3. Stage 1 audit — documentation review
4. Stage 2 audit — on-site assessment of QMS implementation
5. Certification decision and issuance of ISO 13485 certificate
6. Surveillance audits (typically annual)
7. Re-certification (typically every 3 years)

Further reading

• MDS-REQ 3 — QMS requirements
• ISO 13485 Overview
• Inspections and Audits

Verifying CAB accreditation scope: Before selecting a CAB, confirm that their accreditation scope explicitly covers your device type and classification level. Request a copy of the CAB's accreditation certificate or scope document from the SFDA. If your device type is not listed in the CAB's scope, the SFDA may not accept their certification for MDMA purposes.