SFDA Enforcement & Compliance
SFDA enforcement authority
The SFDA has broad enforcement powers under the Medical Devices Law to ensure devices on the Saudi market are safe, effective, and compliant. These powers include:
- Market surveillance — systematic monitoring of marketed devices
- Inspections — of manufacturers (local and overseas), importers, distributors, ARs, and healthcare facilities
- Import controls — SFDA can issue import alerts to prevent non-compliant devices entering the KSA
- Seizure and detention — of non-compliant or suspect devices
- Market withdrawal — ordering removal of devices from the market
- Mandatory recall — requiring manufacturers/ARs to recall unsafe devices
- MDMA and MDEL suspension or cancellation — withdrawal of registration or license
- Penalties — financial and administrative penalties under the Medical Devices Law
Consequences of non-compliance
| Non-compliance | Potential SFDA response |
|---|---|
| Marketing without MDMA | Seizure, market withdrawal, penalties |
| False or misleading technical file | MDMA suspension, investigation |
| Failure to report adverse events | Warning, MDMA suspension |
| Unapproved advertising | Advertising withdrawal, warning, penalties |
| Non-compliant labelling | Warning, market withdrawal |
| Expired MDEL | Cessation of operations |
Cooperation with SFDA
Manufacturers and ARs are expected to cooperate fully with SFDA inspections and requests for information. Prompt and transparent engagement with the SFDA — including proactive notification of device issues — is the best approach to compliance and maintaining a positive regulatory relationship.