What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track?
Question
What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track?
Answer
For information about the technical documentation required to obtain TFA Marketing Permissions , please refer to MDS-G5- Guidance on Requirements for Medical Device Listing and Marketing Authorization:
https://sfda.gov.sa/sites/default/files/2020-09/MDS-G5.pdf
