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The typical time frame for obtaining Class C medical device registration in Saudi Arabia is approximately 3 to 6 months from the date of submission of a complete and compliant application to the Saudi Food and Drug Authority (SFDA).
Breakdown of the Time Frame
| Stage | Estimated Duration |
|---|---|
| Preparation of technical documents | 4 to 6 weeks (varies) |
| Establishment License (EL) approval | 2 to 4 weeks |
| Submission of registration | Immediate upon readiness |
| SFDA Technical Review | 3 to 6 months |
| Response to SFDA queries | 2 to 4 weeks per round |
| Issuance of registration certificate | Immediately after approval |
Important Notes
Preparation Time: The document preparation period depends on your readiness, including compiling technical files, clinical data, and appointing an Authorized Representative.
Review Period: SFDA’s review timeline for Class C devices is longer than for lower classes due to the higher risk level and complexity.
Query Responses: Timely and complete responses to SFDA’s information requests can shorten the overall process.
Delays: Incomplete or poor-quality submissions often extend the review time.
Expedited Pathways: Having prior approvals such as CE or FDA clearance can help facilitate a smoother and sometimes faster review.
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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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.
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