FAQ: Saudi Food and Drug Authority requirements for medical devices, and the ISO 13485 quality management system

References reviewed: October 2026

Short, direct answers, with the official references at the end of the page.

Licensing and cost

How much does a medical device warehouse licence cost?

800 SAR per year; a third-party storage licence is also 800 SAR per year.

How much is the authorized representative licence?

2,600 SAR per year, for one to ten years as you choose, with a separate licence for each manufacturer you represent.

How much is the importer and distributor licence?

The importer and distributor licence is annual, and its fee depends on the establishment category in the fees table.

When do I renew the establishment licence?

You may apply up to 60 days before the current licence expires, and the renewal runs from the previous licence's expiry date unless it was cancelled.

What is Ghad?

SFDA's electronic system. The establishment creates its account there and gets an establishment number, and it is where applications such as the Marketing Authorization and the import permit are filed.

What are establishment categories A, B, C and D?

A category given within the import and distribution activity. The fees table sets the licence fee by it, and it sets how quality system evidence is given. The table gives no category to authorized representatives or warehouses.

Do I need a licence for my online store?

An online store belonging to an import and distribution establishment is a sales outlet in SFDA's definition. Its details are listed in the main licence and updated when they change, and the establishment supervises how the requirements are applied there.

How long does it take to get a licence?

The establishment licensing requirements state no processing period for a licence application. What they set is the period for issuing the inspection report after the visit: 10 working days for establishments, and 15 working days for factories.

Quality management system

What is the difference between ISO 9001 and ISO 13485?

• ISO 9001 is a general standard for quality management systems.
• ISO 13485 is the standard for medical device quality management systems for regulatory purposes. Its Saudi edition is SFDA.MD/GSO ISO 13485:2017.

The establishment licensing requirements name the second for quality system evidence, and do not name ISO 9001.

Is an ISO 13485 certificate mandatory?

It depends on your activity:

• Local manufacturers: yes.
• Importers and distributors in categories A and B: yes.
• Importers and distributors in categories C and D: documented evidence or an SFDA inspection report is enough.
• Warehouses: the two clauses do not name them; they prove compliance with the transport and storage requirements.

Who issues an ISO 13485 certificate SFDA accepts?

A conformity and quality management system verification provider accepted by SFDA: an office inside the Kingdom licensed by SFDA, or an office outside it holding accreditation from the International Accreditation Forum (IAF).

What does documented evidence of a quality system mean?

The alternative to a certificate for those for whom documented evidence is enough: documents proving the quality management system is applied under the same standard, or an SFDA inspection report. Among the authorized representative documents, the licensing procedures guide offers proof of application by filling in the quality manual checklist published on SFDA's website.

Marketing Authorization and import

What is MDMA?

A common abbreviation for Medical Device Marketing Authorization. No medical device may circulate in the Kingdom without a valid Marketing Authorization from SFDA.

Who applies for the Marketing Authorization?

• A local manufacturer: applies after its factory is licensed.
• A foreign manufacturer: may choose its authorized representative to apply, once the representative holds its licence.

The application is filed in the Marketing Authorization services in Ghad.

When do I renew the Marketing Authorization?

It can be renewed up to ninety days before it expires, and it must be valid for any consignment to be released for circulation.

What documents are needed to release a medical device shipment?

• the purchase invoice certified by the Chamber of Commerce;
• the bill of lading;
• the customs declaration;
• the consignment's declaration of conformity on the form SFDA sets.

SFDA checks the Marketing Authorization, the authorized representative licence and the importer licence itself, and they must be valid. The application goes through SFDA's clearance services system or the Fasah platform.

How much shelf life must remain at import?

• Shelf life under one year: at least 40% of it remains at the port of arrival.
• Shelf life over one year: at least 7 months remain.

Do I need an import permit for laboratory reagents?

Yes, for chemicals classified as medical devices or supplies, medical laboratory reagents included:

• the application goes through Ghad, with the declaration and undertaking SFDA sets;
• the quantity matches one year of the establishment's need;
• the permit is issued valid for one year.

What is an authorized representative, and when do I need one?

A licensed establishment in the Kingdom that represents a foreign manufacturer in its dealings with SFDA and provides the information and documents SFDA asks for. Releasing any shipment for circulation requires a valid authorized representative licence for its devices.

Storage, traceability and records

Do I need a warehouse licence as a distributor?

You need a warehouse licence or a third-party storage licence. A distributor with sales outlets only may use a storage area inside the establishment that suits the quantities; the other transport and storage requirements still apply.

What is temperature mapping?

A study of how temperature probes are distributed over a set period and space in three dimensions, to monitor and record temperature and find the warmest and coldest points. The measuring devices in the storage area are fixed per the map, and its documents are kept for at least one year.

What does medical device traceability require?

• Effective traceability procedures, documented and applied, for supply, distribution and use information.
• In storage: each item traced by lot or serial number, with its remaining quantity and location.
• With every device: its unique device identification.

What are UDI and the Saudi-DI database?

• Unique Device Identification (UDI): the manufacturer assigns it to the device, made of a device identifier and a production identifier.
• The Saudi-DI database: the manufacturer or its authorized representative submits the device's data to it. The data is available when the device is placed on the market, and is validated at submission and every year.

How many years do I keep records?

• Archive of data, documents and operations: at least 5 years.
• Originals of release documents: 5 years from the release date.
• Dispensing records for high-risk devices on prescription: at least 5 years.
• Transport and storage documents: at least 3 years.
• Destruction record: at least 3 years.
• Storage-condition monitoring and temperature mapping records: at least one year.

Can a used medical device be sold, lent or donated?

Yes, on these conditions:

• a valid Marketing Authorization;
• the device has not passed the expected life the manufacturer set;
• it is free of contamination, and patient data is erased from its memory;
• it passes safety and calibration tests;
• SFDA and the manufacturer or its authorized representative are notified, and the procedures and records are documented.

Reporting, inspection and advertising

When do I report a medical device incident?

Manufacturers, authorized representatives and healthcare providers report to the National Center for Medical Devices Reporting (NCMDR), counted from the incident or from becoming aware of it:

• within 2 days for a serious public health threat;
• 10 days for an incident that led or could have led to death or serious injury;
• 30 days otherwise.

Importers and distributors carry:

• the traceability system and the reporting procedures;
• reporting transport and storage incidents and complaints to the NCMDR;
• reporting non-compliant devices with a handling plan within 5 days.

What does a distributor do when a device is recalled, or a field safety corrective action is issued?

• Stop importing and distributing a device subject to a withdrawal or suspension decision.
• Stop circulating it when the manufacturer's letter says so.
• Keep the stock in the quarantine place until it is disposed of.

Reporting to the NCMDR and the plan fall on the manufacturer or its authorized representative.

What happens if SFDA finds issues during an inspection?

• You answer the nonconformities on the form sent with the report, and attach a corrective action plan within the period SFDA sets.
• You have at most three chances to amend the plan.
• Once it is accepted, you carry it out, notify SFDA when it is done, and get its confirmation.

Do I need SFDA approval to advertise a medical device? What does it cost, and how long does it take?

Yes, before publishing any advertising material, whether aimed at lay users or healthcare professionals. On the separate application route through the e-services portal:

• Review period: 10 days on this route, and 35 days when the material is submitted within the Marketing Authorization application file;
• Approval validity: one year, extendable up to five years under the same number;
• Fee: 3,000 SAR for material aimed at lay users, and 6,000 SAR for material aimed at healthcare professionals.

Your documents

What do I receive? Do the documents guarantee a licence or a certificate?

You receive your documents as Word files in your establishment's name, and you review and approve them your own way before you submit them — and we guide you step by step to issuing your approved edition.

The licence is SFDA's decision and the certificate is the conformity assessment body's decision, and no documents guarantee either. What the package gives you:

• a start from a written system that fits your activity;
• for every duty, its reference in SFDA's documents.

Readiness then comes from applying it and keeping the records.

References