Gulf
Gulf Readiness (SFDA)
Best for: Manufacturers preparing to export to Saudi Arabia and the Gulf.
You receive
- Readiness report
- Document gap list
- Hand-over pack for your representative
Gulf (SFDA & UAE) Phase 2 market
Your ISO 13485 system is your ticket to the Gulf.
Saudi Arabia’s SFDA requires an ISO 13485 quality system for medical device marketing authorization. ISO 13485 and dossier readiness, coordinated with licensed authorized representatives.
Regulatory framework
In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires a Medical Device Marketing Authorization (MDMA) before devices can be placed on the market. A certified ISO 13485 quality system is a core requirement, and foreign manufacturers must appoint a licensed Saudi authorized representative. Other Gulf markets, including the UAE, have their own registration routes. We prepare your quality system and technical dossier so your representative can file with confidence.
Dates and requirements are summarized from the official sources linked on this page. Always check the current official text.
Recommended services
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
DetailsRemote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
DetailsCAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
DetailsPackages for this market
See all packages All markets
Remote Internal Audit
Best for: Manufacturers under ISO 13485, FDA QMSR or EU MDR who need an independent auditor.
You receive
- FDA-presentable audit report
- Nonconformity log
- CAPA recommendations
All markets
Starter Document Review
Best for: Teams who want to test working with us on a small, defined piece of work.
You receive
- Findings report with suggested wording
- 30-min debrief call
FAQ
Are you a Saudi authorized representative?
No. RegVia is not an authorized representative in Saudi Arabia. We prepare your ISO 13485 system and dossier and coordinate with licensed representative partners.
Does a CE certificate or FDA clearance help?
Existing approvals from reference markets can support a Gulf application, but requirements and acceptance differ by authority. We check this case by case against current official guidance.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.