Entry into Saudi Market: Registration with the SFDA is mandatory for marketing and distributing medical devices in Saudi Arabia. Successfully registering a Class D device allows manufacturers to access one of the largest and most growing healthcare markets in the Middle East.

Preparation Time: This phase involves gathering and preparing all necessary documentation, such as technical files, clinical data, risk management plans, and labeling. This can take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of your documentation.

High-Risk Classification: Class D devices are categorized as high-risk medical devices. They are considered to pose the highest potential risk to patients and users due to their intended use or the complexity of the technology.

Review the SFDA’s regulations and guidelines specific to Class D medical devices, which are high-risk and require extensive documentation.

Review SFDA regulations and guidelines specific to Class D medical devices.

Review the SFDA’s guidelines and regulations specific to Class D medical devices. This includes understanding the necessary documentation, labeling, and compliance requirements.

Preparation Time: Preparing the application can take several weeks to months, depending on the complexity of the device and the completeness of your documentation. This phase includes compiling technical documents, clinical data, and other required materials.

Understand Regulations: Familiarize yourself with SFDA’s regulations and guidelines specific to Class D medical devices. This includes understanding the requirements for documentation, labeling, and compliance.