Medical Device Registration in South Korea

Download our white paper on Medical Device Registration in South KoreaThinking of marketing your medical device or IVD in South Korea? South Korea’s market boasts impressive growth potential as well as an evolving device registration process. The MFDS implemented a new registration process in 2015 designed 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 has changed with the amended regulations?

  • How will the changes affect registration timelines?

We'll all these questions and much more in this 5-page white paper.

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