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.
Question
When should medical device adverse event, incident, and complaint be reported?
Answer
The local manufactures, the overseas manufactures, Authorized Representative, Importers, Distributors and the health practitioner must report incidents and adverse events to SFDA upon becoming aware it happens
Question
"How to report medical devices adverse events, incidents and complaints?"
Answer
Through one of the following channels:
• National Centre for Medical Device Reporting (NCMDR) website
https://ncmdr.sfda.gov.sa/default.aspx
• Saudi Vigilance
https://ade.sfda.gov.sa/
• Call center 19999
• Tameni App
Question
What is the National Center for Medical Devices Reporting (NCMDR)
Answer
An organization managing a database of information on safety and/or
performance related aspects of medical devices and employing staff
capable of taking appropriate action on any confirmed problems.
Question
How to comment on standards for national adoption?
Answer
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
Question
How to comment on drafts of guidelines and requirements?
Answer
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
Question
Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?
Answer
Yes, based on bundling/grouping criteria on guidance MDS-G7:
https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf
