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Find out moreThe 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 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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