Medical Device Registration Saudi Arabia

Medical Devices Law

Medical Device Registration Saudi Arabia

Medical Device Registration Saudi Arabia

Our regulatory consulting specialists support market access in the Saudi Arabian medical device market. We know the essential requirements to receive MDMA approval and can set up a strategy plan with you to guide the Medical Device Registration process in Saudi Arabia. To provide you with a quote, please send us information regarding the devices in scope, their risk classes, including the IFUs, DoCs, CE certificates, and QMS certificates. Generally, if the products share the same risk class and intended use, they can be grouped into a single MDMA application. One MDMA application can cover 1-50 products if they have the same intended use, risk class, or function as a system. Specifically, if the products:

• Have the same legal manufacturer
• Have the same intended use
• Have the same risk class
• Have the same design and manufacturing process
• Do not exceed 50 products in total
• Do not exceed 5 technical files per application

Then they can be listed under one MDMA application.

Worldwide support

Qserve is a premier regulatory consulting firm offering comprehensive services for medical devices and in vitro diagnostics, specifically tailored to meet Saudi Arabian regulatory and quality requirements.

• Global Market Access: We specialize in assisting clients to achieve and maintain market access not only globally but also within Saudi Arabia, ensuring compliance with the SFDA's regulations.
• Experienced Local Experts: Our team includes seasoned regulatory and quality experts with in-depth knowledge of the Saudi Arabian regulatory landscape. This expertise enables us to help manufacturers navigate the intricate requirements set forth by the SFDA.
• Practical and Tailored Support: Qserve employs a practical approach, providing support at every step of the regulatory process. Our tailored services ensure smooth and efficient compliance with Saudi regulations, facilitating successful market entry and sustained product availability.