Medical Device Registration in South Korea

Download our white paper on Medical Device Registration in South Korea

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Thinking of marketing your medical device in South Korea? South Korea’s market boasts impressive growth potential as well as an established device registration process. The MFDS implemented a new registration process in 2015 to provide a more transparent market pathway for device companies, especially foreign manufacturers.

While the registration process is similar to that in other established markets, there are some differences. In this white paper, we discuss the steps you need to take to start selling in this promising market. You will learn:

  • What are the registration, reimbursement, and quality system requirements?

  • What are the regulatory authorities overseeing medical technology in South Korea?

  • How are medical devices classified?

  • What is included in a Korean technical file?

We'll all these questions and much more in this 16-page white paper.

About the Authors:

Vincent Lee is the Manager of Emergo's office in Seoul, South Korea.

In-Wha Kim is a Regulatory Affairs Specialist with Emergo's Seoul office.

Related resources:

Related services for South Korea: