.png)
.jpg)
The processing time for Class C medical device registration in Saudi Arabia typically ranges between 3 to 6 months for the core SFDA review after your application submission. However, the total end-to-end timeline from preparation to approval usually spans 5 to 8 months due to additional procedural steps.
Here’s a detailed breakdown of the timeline stages:
🕒 Breakdown of Processing Time for Class C Medical Device Registration
| Step | Estimated Duration | Notes |
|---|---|---|
| 1. Appointment of Authorized Representative (AR) | 1–2 weeks | Time to select and register a local AR if needed |
| 2. Establishment License (EL) Application | 2–4 weeks | For both manufacturer and AR via GHAD system |
| 3. Preparation of Technical Documentation | 4–6 weeks (varies widely) | Depending on existing documentation readiness |
| 4. SFDA Submission and Application Review | 3–6 months | SFDA review of technical file and application |
| 5. Response to SFDA Queries (if any) | 2–4 weeks per query | Timely responses can accelerate approval |
| 6. Issuance of Medical Device Marketing Authorization (MDMA) Certificate | Immediately after approval | Digital certificate available via GHAD portal |
| Total Estimated Time | 5–8 months (typical) | Including preparation and review phases |
📌 Important Notes
Prior international certifications (e.g., CE mark, FDA clearance) may qualify your device for an abridged review pathway, potentially shortening SFDA review time.
Incomplete or non-compliant documentation can cause delays due to requests for additional information.
Arabic translations of labeling and IFU must be ready at submission time to avoid processing delays.
The Establishment License must be valid and approved before device registration submission.
Summary Table
| Phase | Duration |
|---|---|
| Preparation & AR Appointment | 1–6 weeks |
| Establishment License Processing | 2–4 weeks |
| SFDA Review & Queries | 3–6 months |
| Final Approval & Certificate | Immediate |
.jpg "national-cancer-institute-LxPrHCm8-TI-unsplash(1).jpg")
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
.png)
Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
.png)