When applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), it’s important to meet all necessary regulatory requirements to ensure the device is approved for sale in Saudi Arabia. D-class medical devices are categorized as low-risk devices, so the registration process is simpler compared to higher-risk devices, but certain key documents and standards still need to be met.

The Saudi Food and Drug Authority (SFDA) regulates medical devices in Saudi Arabia, including D-class medical devices, which are considered low-risk. The process for registering a D-class device is streamlined but still requires careful attention to ensure compliance with SFDA standards.

In the Saudi Arabian regulatory framework, medical devices are classified into four categories based on their risk to the patient and user. D-class devices are low-risk devices that generally have minimal risk when used as intended. These devices may be simple or non-invasive and are typically used in clinical or home settings.

Make sure that the product meets the definition and classification criteria for a D-class medical device according to the SFDA’s guidelines. D-class devices are typically those that are non-invasive and low-risk, such as certain medical consumables and accessories.

The process to obtain Class C medical device registration with the Saudi Food and Drug Authority (SFDA) typically takes between 3 to 6 months. However, the exact duration can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether the SFDA requires additional documentation or inspections.

Registration Validity: Once a Class C medical device is registered, the registration certificate is typically valid for 5 years.

Registering a Class C medical device with the Saudi Food and Drug Authority (SFDA) offers several significant benefits for manufacturers and distributors. These advantages not only ensure compliance with local regulations but also facilitate access to the growing Saudi medical device market and enhance the credibility of the product.

The duration for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether the SFDA requires additional documentation or inspections.