Medical Device Registration in Saudi Arabia

Regulatory Authority

Saudi Food and Drug Authority (SFDA)

Classification of Medical Devices

Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), Class D (high risk)

Quality Management System

ISO 13485:2016

The information on this page is valid and current as of October 2023. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer

A foreign manufacturer wishing to place Medical Devices in Saudi Arabia must appoint an Authorised Representative (AR) responsible for submitting the documents required in the registration procedure to the local Regulatory Authority – Saudi Food and Drug Authority (SFDA), and for post-marketing surveillance.

The AR forwards to SFDA, via the GHAD electronic system, the medical device technical file containing information on the product and the organisation, including intended use, safety and efficacy, production process and quality control. The technical file must comply with the MDS-REQ1 guideline. The SFDA performs specific evaluation activities on clinical and technical data and, in case of a positive outcome, issues the Medical Device Marketing Authorization (MDMA).

Applicant

The appointment of an Authorised Representative (AR) is required. The AR must obtain an establishment licence issued by SFDA and, for class C and D devices, provide evidence of having implemented a quality management system under the Saudi Standard SFDA.MD/GSO ISO 13485:2016 or equivalent documents.

Validity

Registration is valid for three years. For devices of all other classes that have already been registered in Canada, Australia, Europe, Japan or the USA, the registration is valid until the expiry of the registration in the relevant country.

Documentation Language and Labelling

The technical file for product registration must be drafted in English.

The labelling (labels and instructions for use) for Medical Devices for professional use can be made available in English while that for devices for domestic use shall be provided in Arabic.

Useful information

To register your Medical Devices in Saudi Arabia, you must have already obtained approval in at least one of the following countries: USA, Canada, Europe, Japan or Australia.

Even in Saudi Arabia as of September 1, 2023, manufacturers must implement device identification (UDI) requirements for placing Class B, C and D devices on the market in the territory. The obligation will start on September 1, 2024 for Class A devices, while there is an exemption for custom-made Medical Devices or devices intended for clinical investigations.