Saudi Arabia SFDA Medical Device Marketing Authorization (MDMA): AR, Licences and Process

Saudi Arabia is the largest medical device market in the Gulf, and its regulator, the Saudi Food and Drug Authority (SFDA), has built a system that looks familiar to anyone who knows the EU MDR: similar classes, a technical file assessment and a requirement for a local authorised representative. But it is not a mutual recognition system, and an approval in another country does not give you one in Saudi Arabia. This guide explains the Medical Device Marketing Authorization (MDMA), the roles of the authorised representative and the establishment licence, and how to plan the work.

The framework

The SFDA regulates devices under the Medical Devices Interim Regulation and a series of technical requirement documents, called MDS-REQ documents. MDS-REQ 1 covers marketing authorisation, and MDS-REQ 11 covers post-market surveillance, incident and recall reporting. The SFDA also publishes guidance (MDS-G documents) that explains how to apply them. Check the SFDA website for the current versions, because they are updated often.

Classification

Devices are classified A, B, C or D, with sub-groups for Class A (sterile, measuring and reusable surgical instruments), based on the same 22 rules as the EU MDR. IVDs follow rules aligned to the IVDR. If you have already classified the device for the EU, reuse the rationale, but check any sub-group and software rules. See device classification and the IVDR guide.

The Authorized Representative

The AR is a Saudi entity registered with the SFDA that represents the manufacturer. It submits applications, communicates with the authority, makes sure labelling meets local rules, and supports post-market reporting. Because only the AR can submit, the choice is a real business decision.

• Agree who owns the authorisation, how documents are shared and what happens if you change AR.
• Make sure the AR can support incident reporting and recalls in the timelines of MDS-REQ 11.
• Confirm that the AR is active in the SFDA’s electronic systems.

Establishment licence

Manufacturers, importers and distributors must hold an establishment licence before a device can be authorised or sold. For non-Saudi manufacturers the AR normally manages the application. Licences have a limited validity and must be renewed.

The MDMA process

1. Classify the device and confirm the submission route.
2. Appoint the AR and get the establishment licences in place.
3. Prepare the technical file. The content is close to EU technical documentation: device description, general safety and performance requirements, risk management, verification and validation, clinical evidence, labelling and the quality system. See EU MDR technical documentation.
4. Provide conformity evidence. For example, an EU notified body certificate or a quality system certificate such as ISO 13485 or MDSAP, according to class.
5. Submit through the AR. The SFDA may request more information within short deadlines, and an application can be closed if it is not answered in time.
6. Receive the MDMA and keep it valid: authorisations have a limited validity and need timely renewal, and some changes must be notified within set periods.

After authorisation

• Vigilance and recalls: report incidents and field safety actions through the AR on the timelines in the SFDA requirements. See recalls and FSCAs and post-market surveillance.
• Changes: include Saudi Arabia in your change control assessment.
• Labelling: check the language and content requirements for labels and instructions for use before printing.

Common mistakes

• Assuming a CE mark or FDA clearance is enough on its own.
• Appointing an AR before checking its SFDA registration and support capacity.
• Missing the response deadline for a request for information.
• Letting the authorisation or establishment licence expire.

Frequently asked questions

Can I sell in Saudi Arabia using only my CE certificate?

No. The CE certificate is evidence in the technical file, but you still need an MDMA, an AR and the establishment licences.

Who submits the application?

The Authorized Representative. A manufacturer cannot submit directly from outside the country.

How long does it take?

Technical file assessments commonly take several months, and simplified Class A routes can be quicker. Ask your AR for the current service times.

SFDA requirements and guidance documents change often. Confirm the current position with the SFDA, your AR and your regulatory advisers before you act on this guide.

Related reading

• Global market access beyond the US and EU: place Saudi Arabia in your market plan.
• EU medical device regulations: the model for the SFDA approach.
• EU MDR economic operators: compare authorised representative roles.
• ISO 13485 and MDSAP audit readiness: quality evidence for the technical file.
• RAC (Devices) study material: covers the SFDA and other global systems.

Talk to the AptSkill team

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