KOREA MFDS (KFDA) Medical Device Classification Rules

[BL.THE]

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]

Hope this link helps:

https://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]

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

(broken link removed)

Medical Device Act

(broken link removed)

 

[sreenu927]

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

Regards,
Sreenu