An official government website affiliated with the Government of the Kingdom of Saudi Arabia.

Sat 15 Aug 2026

Beta version

Official Saudi government website domains end with gov.sa

All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

Official Reliable websites use HTTPS

Ensure the website is using the HTTPS protocol.

Registered with the Digital Government Authority under number:

20250831619

Suggestions

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?

2024-02-20

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