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Korea

Medical Device Consulting for South Korea

Emergo Group helps medical device manufacturers obtain regulatory approval in Korea. Through our colleagues in Seoul, South Korea, we can fully assist you with all aspects of compliance with Korea Food and Drug Administration (KFDA) medical device regulations, including registration, quality system compliance and distributor evaluation. Our services for medical device companies entering the Korean market are shown below.

Regulatory Consulting

In-Country Representation

Third Party License Holder and In-Country Representative for South Korea

Quality System Compliance

Medical Distributor Search

Reimbursement Consulting

Reimbursement Registration in South Korea

Registration and Approval

Questions? Call or email us.+1 512 327 9997See list of all offices.

Learn more about Korea

Regulatory Chart - Korea

Download PDF chart that explains the medical device approval process in Korea Download copies of device regulations in Korea