Saudi Arabia · Saudi Food and Drug Authority · Medical devices
Review target
-
Not published
Legal time limit
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Not published
Steps
6
5 requirements
Application fee
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For devices with new technology and a clear clinical advantage, the SFDA offers free feedback before filing and then puts the marketing authorization request at the front of the review queue. The review itself is not shortened. Some devices can receive a conditional authorization with post-market limits. Medical devices, IVDs and software with innovative features that have no equivalent on the market and offer a considerable clinical advantage.
1. Apply for innovative device designation; 2. Eligibility review; 3. Pre-submission feedback (free); 4. MDMA request with priority; 5. Priority review; 6. Marketing authorization, possibly conditional.
Outcome: Medical device marketing authorization, full or conditional, with possible public announcement.
Legal basis: Medical Devices Law, Article 9, and Implementing Regulation 9.1 to 9.6
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Saudi Arabia: Medical Device Marketing Authorization (MDMA). See all routes on the Saudi Arabia page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.