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
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
Question
"Medical devices adverse event"
Answer
means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat
Question
Incident
Answer
means any malfunction or deterioration in the characteristics or
performance of a device made available on the market, including use-error
due to ergonomic features, as well as any inadequacy in the information
supplied by the manufacturer and any undesirable side-effect
Question
What is the timeframe for reporting adverse event, incident, and complaint?
Answer
Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon
becoming aware that adverse event, incident, a complaint has occurred, as follows:
− Not later than (2) working days from the date of awareness, if the adverse event, incident,
and complaint represent a serious public health threat.
− Not later than (10) working days from the date of awareness if the adverse event, incident,
complaint that results in an unanticipated death or unanticipated serious injury.
− Not later than (30) calendar days from the date of awareness for all adverse events, incidents,
complaints which are not associated with high risks.
− If SFDA initiate a report of adverse event, incident, complaint, the response shall be received
within (5) working days.
