Published February 10, 2017

The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications. Fees will more than double to US$1,000 for a Safety and Efficacy Review (SER) and US$500 for a Substantial Equivalent (SE) review. Processing fees for a device license update will be increased similarly.

Official fees for Class 2 technical document review and KGMP certification will maintain at the same level, but the official fees for Class 1 devices and for minor changes will increase slightly (by US$3/application).

The new fees schedule is expected to take effect in the first half of 2017.

Contact Asia Actual to register medical devices in South Korea.