FAQs

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Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.

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.

The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.

In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.

The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories. You can reach the Guidance on Medical Devices Classification via: https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf

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

If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?

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?

In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure?

If software update for a medical device imported to KSA is released,but this update is only for improvement not due to problem or malfunction in the device,Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?

How medical devices classification must be performed?