From product classification and marketing authorization to establishment licensing, import permits, Authorized Representation and post-market surveillance, we manage every SFDA requirement for medical device manufacturers, importers and distributors in Saudi Arabia.
End-to-end regulatory strategy, licensing, and local representation designed specifically for foreign manufacturers entering Saudi Arabia.
Act as your official in-country legal representative in Saudi Arabia, holding your SFDA device licenses while keeping your distribution network flexible.
Complete dossier preparation, technical documentation review, and submission through the official SFDA GHAD platform for Medical Device Marketing Authorization.
Continuous post-market regulatory compliance, incident reporting, recall handling, and mandatory safety communication management with the SFDA.
Licensing for establishments that import, distribute, or manufacture medical devices in Saudi Arabia, including Authorized Representatives that carry out import or distribution activities.
Import permits and shipment clearance for medical devices, supplies, and accessories brought in for specific purposes such as research, clinical trials, or private use.
Submission on the SFDA Product Classification System to confirm how your product is regulated and which risk class applies, before you invest in registration.
Appointing an independent consultancy as your Authorized Representative prevents distributor lock-in. You retain 100% control over your SFDA registrations while empowering multiple local distributors to sell your products.
Change or add local Saudi distributors without re-registering your medical devices or delaying sales.
We communicate directly with the Saudi Food and Drug Authority on your behalf for renewals, audits, and compliance updates.
As an SFDA-licensed Saudi company with an active GHAD account, we begin your registration as soon as your AR agreement is legalized.
You retain full license ownership. Easily assign or change distributors without losing market access.
Distributor holds your registration. Switching distributors requires full cancellation and re-registration with SFDA.
Review your CE/FDA certifications, ISO 13485, and technical file, then confirm your SFDA risk class through a PCS classification application.
Sign the Authorized Representative agreement, set up your SFDA GHAD account, and secure the MDNR registration and MDEL needed to import or distribute.
Submit your MDMA dossier, or an MDIL for research, clinical trial, or private-use imports, and manage all queries with SFDA officers.
Receive your SFDA approval, clear shipments, authorize local distributors, and stay compliant through ongoing post-market surveillance.
Compliance Gate is an SFDA-licensed Saudi regulatory consultancy dedicated to medical devices and in-vitro diagnostics. We help manufacturers, importers and distributors bring safe, compliant products to the Saudi market and keep them there.
Our leadership brings hands-on experience in regulatory affairs, healthcare quality and patient safety. We understand both sides of the process: what the SFDA expects from a submission, and what hospitals and patients expect from the devices they rely on.
Our mission is simple: make Saudi market access clear, predictable and fully compliant for every client we represent.
A Saudi-registered company licensed by the SFDA, ready to act as your legal representative.
From product classification and registration to licensing, importation and post-market surveillance.
Bilingual communication with you and the SFDA, including Arabic labeling and IFU review.
Your technical files are protected under NDA and handled in line with Saudi data protection law.
Get in touch with our regulatory specialists to review your product portfolio and start your SFDA registration process.
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