Medical Device Registration Saudi Arabia

Qserve is your trusted regulatory consultancy partner for medical device and IVD registration and license holding in Saudi Arabia.

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Medical Device Registration Saudi Arabia

Achieving regulatory compliance with the Medical Devices requirements in Saudi Arabia can be challenging. Qserve provides expert support for registering and maintaining medical devices and IVDs, ensuring timely renewal of your MDMA certificate before it expires. The requirements of Medical device registration in Saudi Arabia closely mirrors the EU framework, particularly regarding technical documentation and conformity assessments.

Do you need assistance with Medical Device Registration in Saudi Arabia or go-to-market strategy?

Qserve is your trusted partner for market access in Saudi Arabia

Contact us

Regulatory Compliance in 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.

Benefits of Qserve engagement

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.

How Qserve can help

Meet our global registrations team to talk about our services:

Regulatory Strategy: Advising on the best approach to comply with Saudi Arabian regulations, including registration and licensing requirements.
Registration Support: Assisting with the preparation and submission of documentation required for product registration in Saudi Arabia.
Quality Management System (QMS) Implementation: Helping companies establish or enhance their QMS to meet Saudi Arabian regulatory standards.
Training and Workshops: Providing education and training sessions on regulatory requirements and compliance best practices specific to Saudi Arabia.
Post-Market Surveillance: Supporting companies in fulfilling their post-market obligations, including adverse event reporting and product recalls.
Local Representation: Acting as a local representative for foreign medical device companies without a physical presence in Saudi Arabia.

Do you want to learn more about Saudi Arabian market access and its regulation?

We provide a comprehensive overview to guide you through: