Hi All - There is a new regulation from MFDS, Korea on reporting Serious Adverse Events occurred globally. Can someone confirm my understanding:
- If a medical device is registered in S.Korea, then adverse events (AE)/serious adverse events(SAE) occurred in-country will be reported to MFDS.
- If an AE/SAE for a registered product in S.Korea occurred outside of Korea, then it requires reporting to MFDS.
If it is outside of Korea, is it just GHTF (now IMDRF) countries - US, EU, Canada, Japan and Australia or all global countries?
If all countries, then how industry is managing this evaluation of the SAE decision for all complaints received world-wide for products registered in Korea?
Thanks
Sreenu
- If a medical device is registered in S.Korea, then adverse events (AE)/serious adverse events(SAE) occurred in-country will be reported to MFDS.
- If an AE/SAE for a registered product in S.Korea occurred outside of Korea, then it requires reporting to MFDS.
If it is outside of Korea, is it just GHTF (now IMDRF) countries - US, EU, Canada, Japan and Australia or all global countries?
If all countries, then how industry is managing this evaluation of the SAE decision for all complaints received world-wide for products registered in Korea?
Thanks
Sreenu