Published: Sep 11, 2019

New Licencing Regime for Medical Devices in the Kingdom of Saudi Arabia

New Medical Devices Regulations Expected in early 2020

Recently the Saudi Food & Drug Authority (SFDA) issued an updated Guide to the Requirements for Medical Device Listing and Marketing Authorisation (Guide). The Guide states that the Medical Device Marketing Authorisation (“MDMA”) application fee will change with effect from 1 October 2019 with a planned increase of between
USD 3,000 – USD 8,000 per application.

The application fee will be based on the number of medical devices and/or accessories applied for rather than the device risk class and leveraged reference market, which is the current point of reference.

The new requirements will also include a new risk classification for medical devices.

In addition to these proposed changes, the SFDA has implemented a deadline of 60 calendar days for MDMA applicants to respond to queries raised in relation to their application. Failure to meet this deadline without just cause will result in an application being withdrawn. The new deadline could mean a shorter process time for applications which will be a positive step albeit with additional pressure which could prove challenging.

The Guide indicates that new medical device regulations will be implemented next year and this could be as early as January 2020. These regulations are eagerly awaited as the current regulations were only supposed to have been an interim measure.

We plan to issue an update in relation to these regulations as soon as they are announced.

 

If you would like to discuss the new licensing regime further, please do contact us:

Julie Bassi
Senior Associate, Healthcare
Jeddah, Saudi Arabia
j.bassi@tamimi.com

Andrea Tithecott
Partner, Head of Healthcare
Abu Dhabi, UAE
a.tithecott@tamimi.com

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