MFDS Introduces Long-term Tracking System for Human Implantable Medical Devices

Long-term Follow-up Investigation System Introduced
to Strengthen Safety Management of High-risk Implantable Medical Devices

The Ministry of Food and Drug Safety has introduced a long-term follow-up investigation system for medical devices to strengthen safety management of implantable medical devices with high risks of side effects after insertion into the human body.

The Ministry of Food and Drug Safety (MFDS) announced on the 4th that it amended and promulgated the "Medical Device Act" with this content on the 31st of last month.

The long-term follow-up investigation for medical devices designates medical devices that are likely to cause frequent side effects after implantation separately, and collects necessary real-use information for each item from participating medical institutions to detect unexpected adverse events early and take prompt action.

The long-term follow-up investigation system was introduced to strengthen monitoring of side effects in domestic breast implant patients after lymphoma cases caused by breast implants occurred in Korea in 2019. The MFDS established the operational foundation through a three-year pilot project.

Since the promulgation will take effect from August this year, the MFDS plans to promptly prepare detailed matters delegated by law, such as methods and procedures for long-term follow-up investigations, and stated that it will continue to develop various policies and operate them rationally to provide a safe medical device usage environment for the public.

This content was produced with the assistance of AI translation services.