The final Law Update of 2022 is here, and it’s packed full of articles. The double edition features two focus areas, first is a spotlight on Energy and Resources and second we feature a collection of articles on Transport and Logistics. The developments occurring in these sectors in the MENA region are unprecedented and our lawyers cover vast themes for you.
The Energy and Resources focus features topics such as diversifying energy resources, solar PV, mining in the Middle East, renewable energy and green hydrogen. From a transport perspective, we draw attention to the Bahrain metro project, discuss the challenges and remedies associated with the repossession of an aircraft, and there is advice on what to consider should a party vary the terms of a shipping contract.
This edition navigates you through updates from across jurisdictions such as, Oman, Jordan, Saudi Arabia, Egypt, Iraq, Qatar, and the UAE. Each article is timely and provides insights into legal issues and cases that are affecting these sectors across the region.Read the full edition
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 Failure to meet this deadline without just cause will result in an application being withdrawn.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.