Published on Nov 24, 2025
The MENA market for medical devices is growing and progressing very fast. Economic diversification initiatives, such as Saudi Arabia's Vision 2030, UAE’s Vision 3030 and Kuwait’s Vision 2035, are driving medical device market expansion, especially in the GCC.
The medical device regulatory landscape in MENA region is experiencing substantial Improvement, but some underlying challenges are still existing.
As close to 95 % of all medical devices in the markets are imported, the main challenges for medical device regulatory affairs in the MENA countries include a lack of regulatory harmonization across the region, leading to diverse local requirements, and difficulties with staying updated with evolving and fragmented regulations. MENA is not a single regulatory market.
Registration requirements, classification rules, approval pathways and timelines vary widely between countries. The GCC efforts toward some alignment of device registration processes and digital submission portals are helping streamline approvals. Also, some countries like Saudi Arabia have significantly updated and modernized its regulations, e.g. new registration systems, local authorised representative rules.
Furthermore, they offer defined pathways, while many others have partial or evolving frameworks, leading to the manufacturer’s managing multiple, and frequently inconsistent submissions for the same device due to different technical documents and other factors. This fragmentation prevents a single file per region submission strategy which results in increased cost, prolonged time to market and increased administrative burden.
Other challenges for international manufacturers include managing different technical and administrative procedures, and the need for strong local expertise to ensure compliance to local regulations. Changes in the regulations are sometimes not published officially, introduced with short implementation lead time or with limited English documentation, which can be confusing.
Are you looking to learn more about Medical Device Regulations in the MENA region or update your existing knowledge? Join our training course “Medical Device Regulations in the Middle East and North Africa” to get an essential overview of the key areas of medical device regulatory affairs in the region. This course will focus on practical aspects and will cover the regulatory requirements and developments in the individual countries as well as discuss harmonisation in the region.