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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

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Registered with the Digital Government Authority under number:

20250831619
Suggestions

Is it mandatory to submit the Field Safety Notice on the company’s account on NCMDR if it is received directly from SFDA via e-mail?

Is it mandatory to submit the Field Safety Notice on the company’s account on NCMDR if it is received directly from SFDA via e-mail?

icon 2024-02-20

Yes, manufacturer through its Authorized Representative (AR) or importer shall report to the SFDA any Field Safety Corrective Action when the KSA is affected within (2) working days from Field Safety Corrective Action issuance date by manufacturer