Authorized Representative services
Your legal representative before the SFDA, from AR agreement to certificate transfers.
Learn moreSFDA regulatory support · ISO 13485:2016 certified · Riyadh, Saudi Arabia
Your trusted regulatory partner for Saudi market access.
We help international medical device manufacturers enter and maintain access to the Saudi market through Authorized Representative services, SFDA registration, technical documentation support and post-market regulatory compliance. Based in Riyadh, IREG provides practical, transparent regulatory support to manufacturers and local distributors throughout the product lifecycle.
15+years of hands-on SFDA expertise
3sectors: medical devices, food and cosmetics
20+countries represented
50+medical companies represented
ISO13485:2016 certified operations
Trusted by manufacturers and distributors
Who we serve
Overseas manufacturers
Looking for an Authorized Representative and MDMA registration? We handle AR appointment and transfers, MDMA registration and renewals, and post-market surveillance.
Services for manufacturers Who we serveLocal companies
Importing, storing or distributing in the Kingdom? We handle establishment and import licences (MDEL, MDIL), warehouse certificates and ongoing compliance support.
Services for importers and distributorsOur services
Everything the SFDA asks of you, handled by our team.
Regulatory affairs services
MDMA dossiers, renewals, updates, UDI / Saudi-DI and post-market reporting.
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Consultation services
Clear answers on classification, pathways and SFDA requirements for your portfolio.
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Saudi market entry consultation
A plan for bringing your products into the Kingdom, product by product.
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Logistics & warehousing services
Warehouse certification and compliant storage for medical devices.
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Distribution search services
Help finding the right distribution partner in Saudi Arabia.
Learn moreSFDA licence
Licensed by the Saudi Food and Drug Authority.
IREG holds an SFDA Consultancy Office License for regulatory consulting on medical devices. The licence below is the one issued to us by the SFDA.
- Licence number
- CO-2026-FO-0007
- Issued to
- Intelligent Regulations Medical Establishment
- Scope
- Consulting services in medical device regulation
- Valid
- 6 May 2026 to 5 May 2031
Our process
From first contact to MDMA certificate, in seven steps.
- 01Initial consultation
- 02AR appointment
- 03Document collection
- 04Dossier preparation
- 05SFDA submission
- 06Query management
- 07Certificate issuance & post-market support
Client voices
What our partners say.
“IREG’s team demonstrated exceptional knowledge of SFDA requirements. Their guidance helped us secure MDMA approvals efficiently and without delays.”
“IREG’s dedicated project management made a complex multi-product registration feel seamless. We always knew exactly where we stood, and every commitment was delivered on time.”
Start with step one
Book an initial consultation.
Tell us about your portfolio and timeline. A specialist will map the regulatory pathway with you.
Talk to a specialistinfo@i-regulations.com
+966 53 530 0129
+966 53 530 0129