FAQ
FAQ
What is the timeframe for reporting adverse event, incident, and complaint?
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.
When should medical device adverse event, incident, and complaint be reported?
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
Who can report?
Everyone can report: users, health practitioners, manufacturers, authorized representatives, suppliers or distributors.
"How to report medical devices adverse events, incidents and complaints?"
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
What is the National Center for Medical Devices Reporting (NCMDR)
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.
How to comment on standards for national adoption?
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
How to comment on drafts of guidelines and requirements?
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?
Yes, based on bundling/grouping criteria on guidance MDS-G7:
https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf
What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track?
For information about the technical documentation required to obtain TFA Marketing Permissions , please refer to MDS-G5- Guidance on Requirements for Medical Device Listing and Marketing Authorization:
https://sfda.gov.sa/sites/default/files/2020-09/MDS-G5.pdf