Saudi Regulators Issue New Guidance on Investigational Medical Devices
The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country.
According to the guidance, all clinical investigations planned to take place in the KSA must obtain SFDA approval; all investigational medical devices involved in such studies must also be approved by the SFDA before legal entry into the KSA.
The guidance includes an application manufacturers and/or sponsors must fill out and submit to the SFDA in order to obtain approval to conduct clinical investigations in the KSA. Information to be included in the application include technical and regulatory data regarding the investigational medical device; proposed clinical investigation design and sites in the KSA; and contact details for the device manufacturer and/or clinical investigator.
Manufacturers and investigators must also submit labeling information for their investigational devices, as well as plans for reporting progress on their studies once underway.