Posts tagged with "Field Safety Corrective Action"



07. January 2020
The updated GN-10: "Guidance on Medical Device Field Safety Corrective Action" is now published as Version 3.6.

06. January 2020
OSCAR is the Online Safety, Compliance Application and Registration System. It is intended to act as the online reporting tool for Field Safety Corrective Actions for cases when there is a field safety corrective action required for medical devices. The OSCAR system has officially launched on 6 January 2020 where Medical Device Dealers can begin submitting FSCA reports to HSA via the online platform. The users will need to apply for access by either: the company’s CorpPass, or the OSCAR ID.