Is the approval of SFDA required to conduct a clinical study on a medical device ?
Question
Is the approval of SFDA required to conduct a clinical study on a medical device ?
Answer
SFDA represented by the medical devices sector requires obtaining prior approval before conducting any clinical study in accordance with the requirements mentioned in the 'Guideline for the Requirements of Clinical Studies for Medical Devices and Products (MDS - G20) and in compliance with the International Standard (ISO 14155) Concerning Good Clinical Practice.
The guidelines of the requirements for conducting clinical studies on medical devices can be referred to through the following links on the SFDA website:
- النسخة العربية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20a.pdfG20)ar.pdf
- النسخة الإنجليزية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20e_0.pdf
