KOREA MFDS (KFDA) Medical Device Classification Rules

BL.THE · Oct 16, 2013

Dear All,

I'm looking for MD classification rules in KOREA.

I understood from an Emergo chart that classification rules are detailled in "South Korea?s Ministry of Food and Drug Safety (MFDS) Notification 2011-49" ...but I couldn't find this file.

Moreover, it seems that there was an update in the classification in june 2013 and maybe new MFDS notification??

Does anyone could help?

Thank you in advance!

evilchilli_420 · Oct 16, 2013

Hope this link helps:

http://www.emergogroup.com/files/korea-4_1-product-classifications-attached-table.pdf

Am not sure if this is the latest regulations but should be able to provide some guidance to start.

Thanks,
N

bio_subbu · Oct 16, 2013

BL.THE said:
Dear All,

I'm looking for MD classification rules in KOREA.

I understood from an Emergo chart that classification rules are detailled in "South Korea?s Ministry of Food and Drug Safety (MFDS) Notification 2011-49" ...but I couldn't find this file.

Moreover, it seems that there was an update in the classification in june 2013 and maybe new MFDS notification??

Does anyone could help?

Thank you in advance!

Please check below links

Changes on the Medical Devices Act in Korea

http://www.mfds.go.kr/eng/eng/index.do?nMenuCode=39&searchKeyCode=77&page=1&mode=view&boardSeq=68159

Medical Device Act

http://www.mfds.go.kr/eng/eng/index...chKeyCode=125&page=1&mode=view&boardSeq=66026

sreenu927 · Oct 17, 2013

Hi..
What is your product. I can help you in classifying your product as per MFDS classification.

Regards,
Sreenu

KOREA MFDS (KFDA) Medical Device Classification Rules

BL.THE

evilchilli_420

bio_subbu

sreenu927

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