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

Thu 13 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

If software update for a medical device imported to KSA is released,but this update is only for improvement not due to problem or malfunction in the device,Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?

قسم

Medical Devices

If software update for a medical device imported to KSA is released,but this update is only for improvement not due to problem or malfunction in the device,Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?

2024-02-20

In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.

تصنيف

Investor