"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.
Question
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?
Answer
* Notification from the authorised representative to the distributor of the details of the problem and the required procedures and bearing full responsibility
* Follow-up in applying the corrective action
* Inform the SFDA of the updates with evidence of communication and follow-up
Question
What is a Field Safety Notice?
Answer
A notification issued by the National Center for Medical Devices Reporting stating the risk associated with the medical device or product and the corrective actions to be taken; To avoid the risk associated with it.
Question
When does SFDA set requirements for corrective actions for reported devices?
Answer
if SFDA deems to the necessity of conducting a study to evaluate the device, according to the frequency or severity of accidents, it may result in the addition of some conditions, which will inevitably be based on the methodology of risk analysis based on scientific foundations, and considering the best international practices.
Question
What is the procedure followed to appoint a manufacturer liaison officer or his authorized representative with SFDA?
Answer
You must adhere to the announcment for responsible person for medical devices post market surveillance: https://www.sfda.gov.sa/ar/medicaldevices/circulations/DocLib/MD-ddd.pdf
Question
"What is Field Safety Corrective Action?"
Answer
Means an action taken by a manufacturer to reduce or remove a
risk of death or serious deterioration in the state of health
associated with the use of a medical device that is already placed
on the market.
The following are examples of these types of procedures:
• Checking the device to ensure that it is free from problems
• Repairing the device • Calibrating and adjusting device settings
• relabeling the device
• Destroying the device • Notifying patients about the problem of the device
Question
SFDA urges home users to report accidents and problems of home use medical devices
Answer
Home use medical devices reports
Question
Are the requirements for reporting incidents and adverse events of medical devices included in clinical studies different from the general requirements?
Answer
Do not differ, rather, it is the legal representative / The factory informs the authority in case of accidents and deaths in accordance with the announced reporting standards
Question
What should be done immediately after the incident?
Answer
• Do not move the medical device or its accessories unless it poses a danger to the patient or medical staff.
• Do not change the control settings for any medical device.
• Do not disconnect or dispose of any disposable or disposable accessories or parts such as wires, catheters, electrodes, tubes belonging to the medical device ... etc., as their presence is important in understanding the event.
• Adequate capture of photos.
• Document: who was there, who worked, what happened, etc.
• Report the event to SFDA.
Question
complaints
Answer
written, electronic or oral communication that alleges deficiencies
related to the identity, quality, durability, reliability, usability, safety or
performance of a medical device that has been released from the
organization’s control or related to a service that affects the performance
of such medical devices
