Korean Post Market Surveillance and Recall Regulations

SpartanBio

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

Thanks
 

SpartanBio

Involved In Discussions
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

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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