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Adverse Event and Serious Adverse Event Reporting - Korea

sreenu927

Quite Involved in Discussions
#1
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
 

craiglab

Involved In Discussions
#2
My understanding back in 2017 is there was a proposed change to the reporting requirements that went out for industry review but I wasn't aware any changes went into effect.

Do you have a translation of the new regulations?
 
#3
Hi,

It doesn't mean that any AE/SAEs occurred out of South Korea need to be reported to MFDS. It is generally applicable for products cleared in Korea and related to FSCA or recalls. MFDS monitors other government agencies' website worldwide on a regular basis so anything posted to one of websites will be detected by MFDS immediately and contact your Korea representative for clarification.
If FSCA or recalls affects Korea, then should follow AE/SAE reporting procedure.

Thanks,
DYS
 
#4
Hi, I am working in medical device area in Korea.

Regarding the topic, basically, the report should be done by the licensed person (or company) from MFDS( Korea FDA.)

Please visit my contact information in the profile.

Thanks.
 
#5
Hi, I am working in medical device area in Korea.

Regarding the topic, basically, the report should be done by the licensed person (or company) from MFDS( Korea FDA.)

Please visit my contact information in the profile.

Thanks.
Hi to all,
so if I well understood the Foreign events to be reported to South Korea are only the ones related to field action or recall? Or do we have to report all Foreign events reported to other country authorities?

Please help me answering this.

Thank you

BR
Enrico
 
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