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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Thu 25 Jun 2026
Beta version
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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.

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Government websites use the protocol. HTTPS for encryption and security.

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

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Registered with the Digital Government Authority under number:
20250831619
Suggestions

FAQs

 Authorized Representative (AR) should respond to SFDA with any remarks and justifications within the specified period.

The manufacturer should fill out the risk assessment form

No, it is necessary to fill out the risk assessment form in the guideline.

The manufacturer is responsible for monitoring its medical devices, and informing users about any instructions for the safety or quality of the medical device. If there is any problem related to supplying or using the device, the manufacturer should inform the SFDA directly.

. Acknowledgement of the Authorized Representative (AR) to inform the users when the Field Safety Notice is issued, and the preventive and corrective actions related to it. . Acknowledgement of the health care provider to complete the corrective action. .  Maintenance/service report. . Any other document according to the type of the Field Safety Notice and the corrective action.  

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Last update date: 13/10/2024 at 12:16 PM Saudi Arabia time