MEDICAL DEVICE REGISTRATION FEES INCREASE IN KOREA

The Korean government increased 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 in May of 2017.  Fees are now 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 amendment will be increased to US$700 for an SER device and US$400 for an SE device.

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).