[Certification] (Korea) Fitness possibility of medical device query

If you have a question whether your product is medical device or not in Korea, you can get an answer from KFDA(Korea Food & Drug Administration].

First you should make a document, and submit it to KFDA through FAX(043-719-3718).

And you can give a question to them(043-230-0423).

 

contents of document
purpose and definition	Instructions
structure	product picture
raw material	Specification
performance	performance property

 

The judgment take roughly 2 weeks.