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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 bodyAcceptable for...
SFDA-accredited CABClass A and B devices (mandatory); Class C and D (acceptable)
IAF-accredited CBClass A and B devices (acceptable alternative)

For Class C and D devices, the SFDA may additionally require an SFDA inspection or direct audit of manufacturing facilities, regardless of CAB/IAF certification.

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​