Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.
Timelines, and Requirements for SFDA Fees for Medical Devices
1. Device Classification and Fees
SFDA fees for medical device marketing authorization (MDMA) vary by risk classification:
- Class A (Low Risk): SAR 15,000, with a review time of 35 working days.
- Class B (Moderate Risk): SAR 19,000, with a review time of 35 working days.
- Class C (High Risk): SAR 21,000, with a review time of 35 working days.
- Class D (Very High Risk): SAR 23,000, with a review time of 35 working days.
These fees ensure a thorough evaluation based on the safety and risk level of the device.
2. Updates to MDMA Applications
For modifications to existing MDMA applications, the SFDA has categorized fees based on the type of update:
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- Adding devices/models: SAR 5,000 (reduced fees).
- Instructions for Use (IFU) updates: SAR 1,100 (administrative fees).
- Label updates: SAR 1,100 (administrative fees).
- Update advertising materials: SAR 1,100 (administrative fees).
- Changes to device design: SAR 5,000 (reduced fees).
- Brand name change: SAR 5,000
- Jurisdiction or classification changes: Full fees apply.
- Renew design examination: SAR 1,500
- Change jurisdiction: Full fees apply.
- Change classification: Full fees apply.
- Change manufacturer address/name: Full fees apply.
- Minor change manufacturer name or address: 5000 SAR
- Change notified body: Full fees apply.
- Change Notified Body with a transition period letter: 5000 SAR
- Change notified body due to Brexit (Same NB different number) : 5000 SAR
Timely updates are crucial to maintaining compliance with SFDA guidelines.
3. Authorized Representative Applications
Foreign manufacturers without a legal entity in Saudi Arabia must appoint an authorized representative. Application fees and review times for these representatives are integral to the approval process.
Key Takeaways
Understanding the SFDA fees for medical devices ensures manufacturers can plan effectively for compliance costs. From classification-based evaluations to application updates and representative fees, the SFDA’s structured approach promotes safety and quality across the medical device sector.
For more details on SFDA fees for medical devices or support with your application, consult with experienced regulatory consultants to streamline your entry into the Saudi market.
