Korean Post Market Surveillance and Recall Regulations

SpartanBio

Involved In Discussions
#1
Does anyone know if Korea has any specific regulations surrounding recall reporting, Post Market Surveillance or vigilance?

Thanks
 
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SpartanBio

Involved In Discussions
#3
Further to this does anyone know if Korea has specific forms that are required to be filled out and who we actually need to report to?
 
E

edgar123

#4
Hi,
Here is the link to the reference document that contains the forms.
The attachment contains a file that itself contains the forms in Korea.
You need a special software to open the document (hansoft).

I admit it's not user friendly...
 
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