Korea Regulatory Reform: Medical Device Registration and Mobile Health Products

In late January of 2015, the Ministry for Food and Drug Safety (MFDS) announced a revised regulatory process for medical device registration in Korea.

Currently, applicants first submit the device registration application. Then, after the application is approved, the applicant undergoes a Korea Good Manufacturing Practice (KGMP) audit and receives a KGMP certification. However, starting in January 2016, applicants must first undergo a KGMP audit and receive a KGMP certification. After this initial step, applicants can then submit both the medical device registration application and the KGMP certification.

On February 9, 2015, the MFDS also announced that it will develop regulations to reform mobile health products, likely by the end of 2015. The reforms will take into account mobile medical device product regulations in the International Medical Device Regulatory Forum (IMDRF) countries as well as mobile device technology trends.