FAQs

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if SFDA deems to the necessity of conducting a study to evaluate the device, according to the frequency or severity of accidents, it may result in the addition of some conditions, which will inevitably be based on the methodology of risk analysis based on scientific foundations, and considering the best international practices.

A notification issued by the National Center for Medical Devices Reporting stating the risk associated with the medical device or product and the corrective actions to be taken; To avoid the risk associated with it.

* Notification from the authorised representative to the distributor of the details of the problem and the required procedures and bearing full responsibility * Follow-up in applying the corrective action

An email will be sent from the National Center for Medical Devices and Products Reports stating that the Field Safety Corrective Action has been closed.

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.

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:

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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

When does SFDA set requirements for corrective actions for reported devices?

What is a Field Safety Notice?

What is required of the authorised representative in the event that the distributor (s) do not respond to him / her regarding the implementing of Field Safety Corrective Action?

How do I make sure that the Field Safety Corrective Action has been closed?

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”?