FAQ
FAQ
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
what is In-Vitro Medical Device definition
In-Vitro Medical Device:
Means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles
How can I communicate and inquire about clinical trial of medical device?
By contacting the clinical trial of medical device section via email: mdci @sfda.gov.sa