What are the expected outcomes of post-marketing evaluation studies?
Answer
• Corrective actions
• Preventative measurements
• Request additional clinical studies to provide the evidence of the safety and efficiency of the medical device
• Disseminating safety communication to users and health care providers
Question
What do we mean by post-marketing evaluation studies?
Answer
These are studies that are conducted with a scientificmethodology on a medical device to verify its safety / effectiveness as a result of the presence of safety signals on that device that is marketed locally
Question
"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?"
Answer
No, the higher standard must be chosen in case there is more than one option.
Question
"What is the allowed period for submitting a corrective plan to implement Field Safety Corrective Action? "
Answer
Five (5) working days, started from the date of informing the SFDA or the date of receiving an inquiry from SFDA regarding Field Safety Corrective Action.
Question
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?
Answer
In the event that the hospital refuses to enter the employee of the authorised representative to sign or deliver the document, the authorised representative must send an official letter explaining the case and the Field Safety Notice, through registered mail to the person in charge by the hospital but if the responsible person is not present at the hospital or refused to sign or receive the required document, the authorised representative employee must raise this case to the higher management inside the hospital.
Question
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”?
Answer
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.
Question
How do I make sure that the Field Safety Corrective Action has been closed?
Answer
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.
Question
"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? "
Answer
* The authorized representative notifies the manufacturer of the Field Safety Corrective Action and provides a statement from the factory about the representative responsible for following up the Field Safety Corrective Action * The approved authorized representative clarifies the limits of his responsibilities according to the agreement with the manufacturer.
