The Saudi Food and Drug Authority (SFDA) regulates the registration of medical devices in Saudi Arabia to ensure safety and effectiveness. The registration process for B-class medical devices is a structured procedure that involves several key steps. Below is a detailed guide on how to register a B-class medical device with the SFDA.

In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) regulates medical devices to ensure their safety and effectiveness. The SFDA classifies medical devices into four classes (A, B, C, and D) based on the level of risk they present to patients and users.

B-class medical devices are generally those that present a moderate risk to patients and users. These can include devices like syringes, diagnostic devices, or therapeutic equipment.

The D-class medical device registration process with the Saudi Food and Drug Authority (SFDA) typically takes approximately 3 to 4 weeks to complete, assuming that the application is complete, all required documents are in order, and there are no additional requests for clarification or additional information.

Annual Maintenance: For D-class medical devices, the SFDA requires that registered devices undergo an annual maintenance review to ensure that the information about the device remains accurate and up-to-date.

Legality of Sale: Registration ensures that your medical device is legally allowed to be marketed and sold in Saudi Arabia, which is one of the largest and fastest-growing medical device markets in the Middle East and North Africa (MENA) region.

The D-class medical device registration process with the Saudi Food and Drug Authority (SFDA) typically takes approximately 3 to 4 weeks to complete, depending on several factors, including the completeness of the application and the complexity of the device.

However, D-class specifically refers to devices that fall under the lowest risk category. These devices are considered low-risk, non-invasive, and generally safe with minimal impact on the patient’s health. They often do not require detailed clinical data to support their safety and effectiveness but must still meet certain regulatory standards for quality and performance.