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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? FAQ

"If the authorised representative of a manufacturer has a authorised representation certificate for devices classified with a specific classification, but the device affected by the Field Safety Corrective Action is not from the production line responsible for it even though it is of the same classification, is he responsible for closing the Field Safety Corrective Action for this device? " FAQ

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

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”? FAQ

In the event that the responsible person is not responding / present at the hospital to sign or receive the required document regarding Field Safety Corrective Action, what is the procedure taken for this case? FAQ

"What is the allowed period for submitting a corrective plan to implement Field Safety Corrective Action? " FAQ

"in the risk assessment form mentioned in the Guidance on Medical Device Field Safety Corrective Actions, is it possible to choose more than one option for the same standard?" FAQ

What do we mean by post-marketing evaluation studies? FAQ

What are the expected outcomes of post-marketing evaluation studies? FAQ

Guideline for Submitting a claim Evaluation Request of Health and Nutrition Claims Regulations