KFDA (Korea) Device Change Regulations - What are 32 Types of Changes Exempted?

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Ajit Basrur

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#3
KFDA says currently 32 types of changes exempted from a submission of new approval, see info on their web,
http://www.kfda.go.kr/eng/eng/index.do?nMenuCode=42&searchKeyCode=79&page=1&mode=view&boardSeq=66517

Does anyone know what are the 32 types?

Thanks!
Sorry, I searched thru the KFDA website as well as couple of others but could not find any information.

The best way is to contact the KFDA themselves.

Btw, pls let us know if you get the details so that it would be helpful for others.
 
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