Class C medical devices are considered moderate-to-high-risk devices. The Saudi Food and Drug Authority (SFDA) categorizes medical devices into four classes (A, B, C, and D) based on the level of risk to patients. Class C devices include items that typically interact with the circulatory system or central nervous system, such as surgical instruments, diagnostic devices, and active implantable devices. Because of the potential risk, these devices are subject to stringent regulatory oversight during the registration process in Saudi Arabia.

Non-Saudi manufacturers must appoint an Authorized Representative (AR) based in Saudi Arabia. The AR will liaise with the SFDA and is responsible for the device’s registration and post-market surveillance.

Legal Authorization: SFDA registration provides the legal authorization to market and distribute your medical device within Saudi Arabia. It ensures that the device complies with national regulations and standards.

Preparation Time: The time required to prepare the necessary documentation, ensure ISO 13485 certification, and appoint an authorized representative can vary based on your readiness.

Regulatory Compliance: The device has met SFDA’s regulatory standards, which include safety, effectiveness, and quality requirements specific to Class B devices.

Confirm that your device is classified as Class B according to SFDA guidelines. This ensures that the registration process and requirements are correctly identified.

Preparation Time: Time spent gathering and preparing necessary documents and certifications. This varies depending on how quickly you can compile the required information.

Confirm that the device is accurately classified as Class B according to SFDA guidelines.