Medical devices that are innovative play an important role in improving and facilitating the quality of life of both patients and physicians. Having delayed access to Innovative Medical Devices may restrict access to technologies that offer superior effectiveness and may limit physician and patient options.
The Saudi Food and Drug Authority has introduced a pathway for Innovative Medical Devices with the goal of accelerating the regulatory process while ensuring safety and effectiveness to allow patients access to novel technologies.
For manufacturers, these guidelines provide information on the designation criteria, associated review processes, as well as the features of the pathway.
This guidance outlines the criteria for designating Innovative Medical Devices, the requirements for applying through the Innovative Medical Devices Pathway, and the submission process for such applications.
Innovative Medical Devices extends this guidance to innovators, developers, manufacturers, and authorized representatives.
Click this LINK to know more about this guidance.