The first Law Update of 2024 is here, and our first focus of the year spotlights Healthcare and Lifesciences, a sector that is undergoing significant growth and development across the MENA region.
Our focus provides an insight into some of the most important regulatory updates across the region, such as the UAE’s groundbreaking law on the use of human genome, Kuwait’s resolution on nuclear and radioactive materials, the new regulations for healthcare services in Qatar, Egypt’s healthcare regulatory framework, and the impact of the Saudi Civil Transactions Law on the healthcare and life sciences sector … and there is so much more!
Beyond the healthcare pages our lawyers share with you multi-sector insights where you will discover articles on Dubai’s DIFC regulatory framework for startups, Bahrain’s commercial agencies law, and we also shed light on Kuwaiti civil code and the advantages of setting up a joint stock company in Saudi Arabia.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 Failure to meet this deadline without just cause will result in an application being withdrawn.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.