The Kingdom of Saudi Arabia (KSA) has officially introduced the new Medical Devices Regulation, which is expected to come into effect by 2021.

The Regulations were approved by the Saudi Government through Royal Decree No. (M/54) and will replace the temporary Regulations currently in effect but retain most of their rules.

The new Regulation will be the basis for reference that will allow the Saudi Food and Drug Authority (SFDA) to regulate the entry of Medical Devices into Saudi Arabia efficiently and safely.

Marketing Authorisation Applications through the GHTF

The SFDA may recognize and accept applications for Medical Devices (Medical Devices Marketing Authorization MDMA) from one of the founding countries of the former Global Harmonization Task Force (GHTF) – an international volunteer group of representatives for medical regulation authorities – such as the EU, USA, Canada, Japan and Australia. However, such applications through the GHTF will only be accepted only until 1 January 2022.

After 1 January 2022, applications for registration must be submitted to the SFDA through the Technical File Assessment (TFA) procedure, which requires manufacturers to provide more documentation to demonstrate the conformity of the device.

At the moment, according to the GHTF procedure, the submission of the Technical File Assessment (TFA) is still optional but the SFDA reserves the right to request it if deemed necessary.

How to register a Medical Device in Saudi Arabia

To register the device with the SFDA identifying the applicable procedure, you must first identify the hazard class of the Medical Device.

In this regard, the SFDA has published Version 5.0 of the “Saudi FDA Products Classification Guidance” which provides classification criteria and rules, based on what has already been defined by the MDR (EU) 2017/745.

Foreign manufacturers of high-risk Medical Devices must also appoint an Authorised Representative responsible for device registration and compliance with Saudi regulations, said registration must be done through a new system, the electronic platform GHAD.

Support for the registration of Medical Devices in Saudi Arabia

Thanks to our strategic-regulatory consulting services we can support you while registering your Medical Devices in Saudi Arabia. Contact us for more information.

Sources:

Royal Decree No. (M/54), Kingdom of Saudi Arabia (KSA), 18 february 2021

Medical Devices Regulation, SFDA, 18 february 2021

“Saudi FDA Products Classification Guidance”, SFDA, 22 may 2021