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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
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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 Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?

If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?

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No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.

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Last update date: 20/02/2024 at 01:10 AM Saudi Arabia time