This month we bring you a special focus on a continent that boasts the world’s largest free trade area, a diverse economic make-up and increasing political stability. The latest edition of Law Update focuses on Africa, a territory that continues to be an attractive business and investment destination.
Like the rest of the world, Africa is still re-building from the impact of COVID-19, however, there continues to be an optimistic view of the opportunities the continent presents. An example of the appetite for investment into Africa was captured in a report we commissioned, titled Legal Leaders in MENA. Our survey of legal leaders revealed a resounding desire to expand into new territories, with 81% naming Africa as their investment destination of choice.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 Failure to meet this deadline without just cause will result in an application being withdrawn.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.