Medical Devices Law
Medical Device Registration Saudi Arabia
Registering medical devices in Saudi Arabia can be a complex and time-consuming process. The Saudi Food and Drug Authority (SFDA) enforces strict regulations to ensure the safety, quality, and effectiveness of all devices entering the market. For manufacturers, this means navigating a detailed registration process, meeting extensive documentation requirements, and adhering to local standards.
At Qserve, we specialize in simplifying this journey. Our team provides expert guidance to help manufacturers achieve compliance with SFDA regulations and maintain it over time. From developing a strategic approach to managing every detail of the submission process, we ensure a smooth and efficient path to market.
Whether registering a single device or an entire portfolio, Qserve's tailored services allow you to focus on what matters most: delivering innovative and reliable medical solutions to your customers. With our proven expertise, we streamline the regulatory process, reduce time to market, and help you achieve success in Saudi Arabia.
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 a quote, please send us information regarding the devices in scope and 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.