"How medical devices classification must be performed"
Question
"How medical devices classification must be performed"
Answer
The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories.
You can reach the Guidance on Medical Devices Classification via:
https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf
