GLGlossary
Post-market management.
The quality and safety management and regulatory reporting work that continues even after approval or certification is obtained.
It includes standard code (UDI) registration, notification of changes, periodic reporting, and responding to adverse events. The scope required can vary depending on the product type and class. The necessary work can be managed either by outsourcing it or by running it in-house.
Related work & timing
These are ongoing maintenance tasks that continue after the certificate is issued, such as UDI registration, change management, and periodic reporting, and can be outsourced on a monthly basis by class.
Basis
- Medical Devices ActView source →
- Regulation on Integrated Information Management of Medical Devices (MFDS Notification)
- Regulation on the Management of Safety Information such as Adverse Events of Medical Devices (MFDS Notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.