Government Begins Developing Approval and Review Guidelines for Wearable Medical Devices

The government has decided to develop approval and review guidelines for wearable medical devices.

Jong-seok Kim, Private Committee Chair of the Regulatory Reform Committee / Photo by Younghan Heo younghan@

On the 24th, the Ministry of Food and Drug Safety announced this during a visit by Kim Jong-seok, chairman of the Regulatory Reform Committee under the President, and 10 affiliated committee members to Hyundai Motor Group's Robotics LAB in Uiwang-si, Gyeonggi-do.

The Robotics LAB is Hyundai Motor Group's research organization that implements hardware and software for next-generation mobility through the convergence of various robotic technologies.

Chairman Kim Jong-seok toured the development site of medical devices such as joint robots for rehabilitation training and mobility convenience for the disabled and elderly, listened to expert opinions on various robot-related technologies including advanced medical devices, autonomous driving, and robot control systems being developed and researched by the Robotics LAB, and then discussed regulatory improvement plans for the advanced medical device industry.

The Robotics LAB proposed the need to simplify clinical trials for wearable robots with low risk to the human body, and the Regulatory Reform Committee and the Ministry of Food and Drug Safety agreed to actively reflect procedural simplification measures when revising medical device-related regulations.

In particular, the Ministry of Food and Drug Safety emphasized that it will support companies by developing approval and review guidelines for wearable medical devices in response to opinions that support is needed for the approval of medical devices applying new technologies.

Chairman Kim said, "To ensure the rapid market entry of medical devices applying new technologies, the Regulatory Reform Committee will actively support discussions on improving the medical device approval system while closely communicating with the industry and relevant ministries."

Earlier, the Regulatory Reform Committee visited a site in March to inspect certification testing facilities for firefighting equipment. In addition to the Regulatory Reform Committee, officials from the Office for Government Policy Coordination and the Ministry of Food and Drug Safety attended the event to listen to opinions.