An official government website affiliated with the Government of the Kingdom of Saudi Arabia.

Thu 25 Jun 2026

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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.

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.

Registered with the Digital Government Authority under number:

20250831619

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FAQs

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The Annex specifies the requested information in the Field Safety Notice, other information may be added by the manufacturer, according to the type of the problem and the corrective or preventive actions to reduce or remove a risk.

According to requirements and standards of the approved quality management system in the manufacturer.

If users are not responding to the Authorized Representative (AR) or the supplier in regards to implementing the corrective or preventive action and evidence is provided, the necessary actions will be taken to ensure safe use of the medical device.

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

No, destroying the affected devices should be done according to the agreed plan.

An official government website affiliated with the Government of the Kingdom of Saudi Arabia.

Official Saudi government website domains end with gov.sa

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

Registered with the Digital Government Authority under number:

FAQs

Should the manufacturer standardize the contents of the Field Safety Notice so it includes all the contents (Annex (B))? of the guidelines for corrective actions for safety warnings for medical devices and products?

How long does the manufacturer or the Authorized Representative (AR) must keep the records proving implementing the Field Safety Corrective Actions?

What is SFDA procedure if some users do not respond to the Authorized Representative (AR) or the supplier? regarding a Field Safety Corrective Action?

If the Authorized Representative (AR) was unable to obtain a response to provide the corrective plan or ensure if the Kingdom is not affected within 5 working days, what is required and how is the response?

If the corrective action includes destroying the affected devices, and the affected products were collected in the facility's warehouse, is it accepted to delay the destroying of the affected devices for some reasons (Some facilities destroy these products annually or semi-annually)