Saudi Arabia · Saudi Food and Drug Authority · Medical devices
Review target
35 working days
official guidance
Legal time limit
-
Not published
Steps
6
12 requirements
Application fee
SAR 23,000
Effective 28 Feb 2016
No medical device, IVD or medical software may be traded in Saudi Arabia without registration and a marketing authorization from the SFDA. The manufacturer or its Saudi authorized representative files technical documentation through the GHAD system. The agency issues the authorization within 35 business days at most once all requirements are met, and it is valid for up to three years. All medical devices, in vitro diagnostics and software as a medical device in risk classes A to D, and combination products led by the device.
The official review target is 35 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The mdma evaluation fee, fee group 4 (other class iii, class iv, aimd, annex ii list a or registrable ivds) is SAR 23,000 for Effective 28 Feb 2016.
1. Establishment license and authorized representative; 2. Classify the device; 3. Submit the MDMA application; 4. Review (35 days); 5. MDMA certificate; 6. Post-market duties and renewal.
Outcome: MDMA certificate in Arabic and English with national listing numbers, valid for up to three years and renewable. Valid for 3 years.
Legal basis: Medical Devices Law (Royal Decree M/54 of 6/7/1442H) and its Implementing Regulation (SFDA Board decision 3-29-1443), Articles 8 to 10
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).
About 35 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Official maximum to issue the authorization when all requirements are met. Time to fix gaps is not counted. Actual times can differ. | 35 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| MDMA evaluation fee, fee group 4 (other class III, class IV, AIMD, Annex II List A or registrable IVDs)Application · Effective 28 Feb 2016 | SAR 23,000 |
| MDMA evaluation fee, fee group 3 (class IIb, Canadian or Japanese class III, Annex II List B IVDs)Application · Effective 28 Feb 2016 | SAR 21,000 |
| MDMA evaluation fee, fee group 2 (class II or IIa, self-test or listable IVDs under the reference-country class)Application · Effective 28 Feb 2016 | SAR 19,000 |
| MDMA evaluation fee, fee group 1 (all class I and general or exempt IVDs under the reference-country class)Application · Effective 28 Feb 2016 | SAR 15,000 |
Other routes in Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), Innovative Medical Devices Pathway. 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 (28 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.