The MDS-REQ-002 dossier
MDS-REQ-002: the NCBE-registered REC, bilingual consent, AR and CRO licences, ISO 14155, and the application chain.
Free field guide · PDF
Saudi SFDA: Clinical Studies2026 Field Guide
The MDS-REQ-002 dossier, the local-study rule, and the pathway — with the SFDA practice you need.
- Consent
- AR/EN
- First report
- 1 yr
- Study rule
- Local
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The local-study rule
The 2026 AI precedent: two Saudi AI software products won marketing authorization after local clinical studies plus PMCF.
The pathway
The Innovative Medical Devices Pathway: early guidance, the local-in-charge requirement, and one-year progress reporting.
Sources & scope
- sfda.gov.sa, SFDA Grants Marketing Authorization for Two Saudi AI Software Products.
- sfda.gov.sa, MDS-REQ-002 V4.1 Requirements for Clinical Trials of Medical Devices.
- regulatoryaffairsnews.com, Saudi Arabia's (SFDA): Requirements for Clinical Trials.
This guide is market-access intelligence, not regulatory or legal advice. SFDA clinical requirements, pathway criteria, and reporting rules change — professional review is required before business use.
Market Access Strategy Session
Saudi on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your SFDA route — MDS-REQ-002 dossier, local-study strategy, and pathway navigation.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team