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
Question
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?
Answer
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
Question
what is In-Vitro Medical Device definition
Answer
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
Question
How can I communicate and inquire about clinical trial of medical device?
Answer
By contacting the clinical trial of medical device section via email: mdci @sfda.gov.sa
Question
What are the clinical trials of medical devices regulated by the SFDA?
Answer
Includes clinical trials aimed to evaluate the safety or effectiveness of a medical device
