A-class medical device registrations are typically valid for 5 years from the date of approval.

The A-class medical device registration with the Saudi Food and Drug Authority (SFDA) offers several benefits for manufacturers, distributors, and healthcare providers. These benefits not only enable market access but also ensure that medical devices meet safety, quality, and regulatory standards.

The processing time for registering an A-class medical device with the Saudi Food and Drug Authority (SFDA) typically ranges between 4 to 12 weeks. This timeframe can vary depending on several factors, including the completeness of your application, the complexity of the device, and the SFDA’s workload.

A-class medical device registration with the Saudi Food and Drug Authority (SFDA) refers to the process through which medical devices classified as low risk (Class A) are registered with the SFDA for sale and distribution in Saudi Arabia. This is part of the regulatory oversight to ensure that medical devices are safe, effective, and compliant with the regulatory standards set by the SFDA.

To register an A-class medical device with the Saudi Food and Drug Authority (SFDA), you must follow a structured process through the SFDA e-Portal (also known as MDRS – Medical Device Registration System).

To apply for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), you must follow a structured process through the SFDA e-Portal (also known as MDRS - Medical Device Registration System).

The timeframe for obtaining A-class medical device registration with the Saudi Food and Drug Authority (SFDA) typically varies based on the completeness of the application, the complexity of the device, and the workload of the SFDA. However, in general, the process can take anywhere from 4 to 12 weeks from the submission of the application to the final approval, assuming there are no major issues or requests for additional information.

The process for applying for A-class medical device registration with the Saudi Food and Drug Authority (SFDA) involves several key steps to ensure that your device complies with the regulatory requirements for safety, performance, and quality in Saudi Arabia. A-class devices are considered low-risk devices, but they still need to meet specific standards for registration.