Saudi SFDA Medical Device Registration (MDMA) Consultants

Saudi SFDA medical device registration, formally the Medical Device Marketing Authorization (MDMA), is required before most devices and IVDs can be placed on the Saudi market. Medfins International helps manufacturers in India and overseas classify products, prepare MDMA technical files for the SFDA GHAD system and coordinate with their Saudi Authorised Representative and licensed importers.

What is SFDA medical device registration?

The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs under the Medical Devices Law and its Implementing Regulation. The central authorisation is the Medical Device Marketing Authorization (MDMA), which confirms that a device meets SFDA’s safety, performance and labelling requirements before it is imported, distributed or used in the Kingdom.

Applications, establishment accounts and licences are now handled through GHAD, the SFDA unified electronic system, which has progressively replaced older standalone portals.

Who needs SFDA registration?

• Foreign manufacturers, including Indian exporters, placing devices on the Saudi market. They must appoint a Saudi Authorised Representative (AR).
• Local manufacturers producing devices in the Kingdom.
• Authorised representatives, importers and distributors, which must hold a Medical Device Establishment Licence (MDEL) for their activity and may only handle devices with a valid marketing authorisation or listing.

The Saudi Authorised Representative

The AR is a Saudi-based establishment licensed by SFDA to act for a foreign manufacturer. It submits the MDMA application on GHAD, is the manufacturer’s regulatory contact with SFDA and supports post-market surveillance, adverse event reporting and field safety corrective actions. The appointment is made by a written agreement that is usually legalised. Many manufacturers use an independent AR so that registrations are not tied to one distributor.

Classification and routes

SFDA uses a risk-based classification broadly aligned with GHTF/IMDRF principles: general medical devices in Classes A to D and IVDs in Classes A to D, with Class D the highest risk. The class decides the documents required and how deeply SFDA reviews the file.

• MDMA is required for most devices, particularly medium and high-risk products.
• MDNR listing: the Medical Devices National Registry is used to list devices and establishments. Certain low-risk devices that are exempt from full MDMA are handled by listing rather than full review.

Whether a given product qualifies for listing or needs full MDMA depends on its class and characteristics, such as sterility or a measuring function. We confirm the route against current SFDA requirements before preparing documents.

SFDA considers approvals from recognised reference jurisdictions, such as CE certificates under EU MDR or IVDR and US FDA clearance, as important supporting evidence.

Documents typically required for MDMA

• Legalised AR agreement and manufacturer authorisation.
• Reference market approvals (CE certificate, FDA clearance or others) and Certificate of Free Sale where requested.
• ISO 13485:2016 certificate and Declaration of Conformity.
• Technical documentation: device description, essential principles checklist, risk management to ISO 14971, design verification and validation, and clinical or performance evidence.
• Labelling and IFU meeting SFDA requirements, including Arabic where required.
• UDI information in line with SFDA’s UDI requirements, which are being phased in by risk class.
• Post-market surveillance and vigilance procedures.

Registration process: step by step

1. Product and classification review to confirm scope, class and whether MDMA or listing applies.
2. Appoint a Saudi Authorised Representative holding the appropriate MDEL, and sign a legalised agreement.
3. GHAD account set-up and establishment details for the manufacturer and AR.
4. Technical file preparation in the SFDA format, with reference approvals and labelling.
5. Submission on GHAD by the AR and payment of applicable SFDA fees.
6. SFDA review and queries, with timely responses through the system.
7. MDMA issued, followed by listing of importers and distributors and import clearance.
8. Post-market: vigilance reporting, field safety actions, change notifications and renewal.

Timelines and what affects them

SFDA publishes target review times for its services, but total elapsed time depends on the device class, the strength of reference approvals, dossier quality and the speed of query responses. Legalising the AR agreement and certificates, and setting up GHAD accounts, can take longer than the technical review, so start them early. MDMA validity is time-limited and linked to your supporting certificates, so renewals should be planned well before expiry.

After approval: obligations that keep you on the market

An MDMA is not the end of the process. The manufacturer and AR must report adverse events and field safety corrective actions to SFDA through its national reporting channels, and notify SFDA if a device will be unavailable or discontinued. Significant changes to design, intended use, manufacturing site or labelling generally require SFDA to be informed or approve a change before affected products are shipped.

Keeping your CE, FDA and ISO 13485 certificates current is equally important, because an expired reference certificate can affect the validity of your Saudi authorisation and hold up shipments at customs.

Common reasons for delays and queries

• Model names and catalogue numbers that do not match across certificates, labels and the application.
• Expired or soon-to-expire CE or ISO 13485 certificates.
• Arabic labelling or IFU content missing or inconsistent with the English version.
• Incomplete clinical evidence for higher-risk devices.
• AR agreements not legalised, or AR licences not covering the relevant activity.

How Medfins International supports you

We classify your portfolio for Saudi Arabia, compile MDMA technical files, review labelling and coordinate with your Saudi Authorised Representative through GHAD submission, queries and approval. We also help you plan the reference approvals SFDA relies on, through our CE marking and US FDA 510(k) services.

Manufacturers expanding across the Gulf often reuse the same core dossier for UAE registration. Contact us to discuss your SFDA plan.

Frequently asked questions