No. Any SFDA-registered company can act as your AR. The distributor and AR can be different
companies.
About Us
About Us
Your Trusted SFDA Regulatory Partner in Saudi Arabia
Regulatory Standards is a Saudi-based, SFDA-approved consultancy offering
expert-led, risk-reducing regulatory pathways for market access in the Kingdom. With a mission to become the
leading regulatory services provider in Saudi Arabia, we work to foster trust, build cooperation, and ensure
smooth interactions between stakeholders in the regulatory ecosystem.
Our Approach
Expert Guidance. Regulatory Clarity. Seamless Compliance.
We believe strong partnerships and in-depth regulatory understanding are the
foundation of success.
Our experienced team brings deep expertise in SFDA regulations across medical devices, IVDs,
cosmetics, and pharmaceuticals. We work closely with clients and regulatory authorities to resolve
complex challenges, streamline documentation, and accelerate market entry—all while prioritizing
trust, integrity, and continuity in every interaction.
~ FAQ
Frequently Asked Questions
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1. Does the distributor need to be our Authorized Representative (AR)?
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2. What documents are required for SFDA registration of medical devices?
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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
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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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