SFDA Med.Dev: Guidance on National Diagnostic Reference Levels

The Saudi Food and Drug Authority (SFDA) released an updated guidance (7th February, 2023) on "National Diagnostic Reference Levels".

This guidance outlines the national references for identifying and establishing National Diagnostic Reference Levels (NDRL) for various diagnostic ionizing radiation applications, as well as clarifying the requirements for applying these references by the SFDA.

Medical radiation doses that exceed the approved limits and levels, which may be unjustified, are protected by these references without affecting the image's quality or diagnostic capabilities.

Radiology departments with the following imaging modalities are required to comply with this national reference:

1. Computed Tomography (CT) equipment.

2. General X-Ray devices.

3. Mammography devices.

4. All Medical Devices modified or developed within Healthcare facility

Click this LINK to know more in detail about the requirements and annexures.