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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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Official Reliable websites use HTTPS

Ensure the website is using the HTTPS protocol.

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Registered with the Digital Government Authority under number:

20250831619
Suggestions

As a authorised representative of a manufacturer I did not import the affected devices in the Field Safety Corrective Action , do I have to fill out the form “Statement Confirming Saudi Arabia is Not Affected by FSCA”?

As a authorised representative of a manufacturer I did not import the affected devices in the Field Safety Corrective Action , do I have to fill out the form “Statement Confirming Saudi Arabia is Not Affected by FSCA”?

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No, you must first ensure that that none of the affected medical devices included in the Field Safety Notice  were imported and/or placed on the market and/or put into service in Saudi Arabia.

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