No. Any SFDA-registered company can act as your AR. The distributor and AR can be different
companies.
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SFDA Compliance, Start to Finish
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About us
Your Trusted SFDA Regulatory Partner in Saudi Arabia
Committed to bridging the gap between regulatory
authorities, manufacturers,
and local companies.
and local companies.
An SFDA-licensed consultancy providing expert-driven, hassle-free regulatory solutions to help you
confidently enter and thrive in the Saudi market.
Risk-Free Guidance
Expert SFDA guidance to reduce risks and ensure
regulatory clarity.
Strategic Growth Support
We guide every compliance step from approvals to post-market.
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We are Regulatory Standards Consultation Office
Services We Provide
Medical Device Importation & Distribution License (MDEL)
Fast-track your medical device import license in Saudi
Arabia.
Medical Device AR Licensing
Appoint a local SFDA-registered company to act as your official AR.
Product Classification System (PCS)
Classify products and define required SFDA registration
steps.
Medical Device Marketing Authorization (MDMA)
Secure SFDA approval to market medical devices and IVDs.
Unique Device Identification (UDI)
Register devices under the UDI system to ensure traceability and compliance.
Post Market Surveillance
Fulfill incident reporting and safety obligations via the National Center for Medical Devices
Reporting.
~ FAQ
Frequently Asked Questions
-
1. Does the distributor need to be our Authorized Representative (AR)?
-
2. What documents are required for SFDA registration of medical devices?
-
You need a full technical file that includes:
- Product description
- Design and manufacturing process
- Safety and performance validations
- Risk management file
- Clinical Evaluation Report (CER)
- Post-market surveillance plan
- ISO-13485 certificate
- Audit report for the same ISO
-
3. What is AR ?AR stands for Authorized representative, as per SFDA, any legal manufacturer outside of the kingdom, if they need to register devices with SFDA must appoint a local Authorized representative.
(AR = Manufacturer registration) -
4. What is MDMA ?MDMA stands for medical device marketing authorisation, any LM who wants to sell medical devices in Saudi arabia, first needs to apply for MDMA license once received, can only market their products in KSA.
(MDMA = Product registration)
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