After receiving D-class medical device registration approval from the Saudi Food and Drug Authority (SFDA), it's important to understand and follow several post-approval requirements to ensure ongoing compliance with Saudi regulatory standards. These actions will help maintain the device's marketability and ensure it continues to meet safety and quality standards.

For D-class medical device registration with the Saudi Food and Drug Authority (SFDA), the technical document requirements primarily focus on demonstrating that the device meets the safety, performance, and quality standards set by the SFDA. While D-class devices are considered low-risk, they still need to provide sufficient documentation to support their compliance with SFDA’s regulations.

Processing Time: The typical registration time for D-class devices is approximately 1 to 3 months from the date of submission to the SFDA, assuming the submission is complete and meets all requirements.

D-class devices are categorized as low-risk devices that do not involve invasive procedures, and are typically non-critical or non-invasive (e.g., bandages, non-invasive diagnostic devices, etc.).

What it is: A certificate showing the legal status of the manufacturer in their home country (e.g., a certificate of incorporation or business license).

The registration process for D-class medical devices with the Saudi Food and Drug Authority (SFDA) is designed to ensure that low-risk medical devices are safe and meet regulatory standards. Below is a comprehensive guide covering the procedures, required materials, and precautions for applying for D-class medical device registration with the SFDA.

To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you must use the SFDA’s Medical Device Electronic Services (MDES) portal. This is the official online platform for submitting medical device registration applications in Saudi Arabia.

The registration process for D-class medical devices with the Saudi Food and Drug Authority (SFDA) is generally faster and less costly compared to higher-risk medical devices. However, the exact costs and timeline can vary depending on several factors such as the complexity of the device, the required documentation, and the services provided by the local authorized representative (LAR).