Welcome to the Saudi Arabia focus edition of Law Update.
One of the key markets in the Middle East and North Africa (MENA) that continues to lead from the front is the Kingdom of Saudi Arabia (KSA). As the largest country in the Middle East and the 18th largest economy in the world, the progress KSA continues to make is underpinned by its Vision 2030 that envisions developing the country as an investment powerhouse and hub that ultimately connects Asia, Europe, and Africa. Given Saudi Arabia’s significance to the regional economy, our team of experts have prepared a range of pertinent articles that provide insights into new laws, regulations, and the legal landscape in the Kingdom.
This edition will provide you with an up-to-date guide on matters such as; the framework issued by the Saudi Central Bank on IT governance, the anti-corruption landscape under Vision 2030; we also provide practical tips for dispute avoidance. This is only a snapshot; there are many more articles within the KSA focus section for you to read, which we hope you will find valuable and enjoyable.Read the 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 Failure to meet this deadline without just cause will result in an application being withdrawn.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.