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.
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
Does SFDA require corrective action for all reported incidents of medical devices and products?
Answer
Not necessarily, and regulatory bodies often take the manufacturer's recommendations into account in such cases, and it is not prohibited to add some requirements according to each case separately.
Question
What are the obligations of importers and distributors regarding medical devices post-marketing?
Answer
Refer to SFDA requirements in this regard, as well as the following procedural rules and guidelines: • Implementing Rule for licensing facilities (MDS-IR4) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Post-Marketing Control Implementing Rule (MDS-IR7) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Relevant Guidance
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
