Medical Devices

extending deadline for receiving requests for marketing authorization applications via GHTF route

extending deadline for receiving requests for marketing authorization applications via GHTF route
Publication Date
Applying Date
2020-12-28

Question

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.


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