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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

If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?

If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?

icon 2024-02-20

Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.