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Find out moreWelcome to the latest edition of Law Update titled “Rise of Generative AI.”
In this edition, we dive into the dynamic world of Technology, Media, and Telecommunications (TMT) across the Middle East and North Africa (MENA) region. TMT continues to play a vital role in positioning the region as an international business and social hub, driving significant growth and innovation.
Our focus in this Law Update is on the sector’s ongoing potential to advance and propel the region toward a more digital economy. We explore the benefits of embracing a digital transformation and how local authorities have responded by enhancing regulations to accommodate the evolving TMT landscape.
This edition covers a range of topics, including – the new Telecommunications & Information Technology Law in Saudi Arabia, the intricacies of trademarks in the Metaverse, and the legal challenges faced by the video game industry. Additionally, we take a regional perspective, discussing jurisdictions such as Kuwait, Saudi Arabia, UAE, Oman, and Bahrain to provide a comprehensive understanding of the TMT landscape.
We hope you thoroughly enjoy this packed issue of Law Update, filled with captivating articles that address key legal issues within a vital sector for the region.
Read the full editionThe Saudi Food and Drug Authority (“SFDA”) issued a guidance document on 8 January 2023 to define and clarify the requirements for manufacturing medical devices at points of care (“POC”) in KSA (“Guideline”). In general, medical devices cannot be marketed or used in KSA unless they are registered and have a Medical Device Marketing Authorization (“MDMA”) from the SFDA. The SFDA issued this Guideline to exempt POC medical devices from the requirement to obtain an MDMA, and it replaces SFDA’s earlier document, Guidance on Patient-matched Medical Devices Using 3D Printers (MDS-G30).
Manufacturing of a POC medical device by healthcare facilities in the Kingdom, which may include:
This Guidance applies to healthcare providers wishing to manufacture POC medical devices within their facilities for their own use and for non-industrial scale (with regard to the magnitude and methods of production), and applies to the following activities:
Medical-grade raw materials must be used and MDMA must be obtained for the software used for printing the medical device, in accordance with the SFDA Requirements for Medical Devices Marketing Authorization (MDS-REQ 1).
Further, the healthcare facility must provide and document information to the SFDA about the 3D printers, including maintenance records. In relation to the MDPS, the healthcare facility must provide and document the MDPS file, which includes information about raw materials, software, equipment, final product, intended use and users.
The requirements below are applicable to all in-house IVDs including:
The healthcare facility must develop/modify and conduct the IVD test for the own use inside the healthcare facility and provide and document information about the IVD test that is intended to be developed or modified.
Guidance is also provided on implantable medical devices.
The healthcare facility must submit to the SFDA an Application Form for POC Medical Devices Manufacturing, which includes:
Yes, it is required that the healthcare facility:
For more information, please contact our Healthcare & Life Sciences sector group, which operates across the region, including in our three Saudi Arabia offices, advising a wide range of healthcare and life sciences clients on entering or operating in the Kingdom.
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