FAQs

 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.

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.

No, the higher standard must be chosen in case there is more than one option.

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

• 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