Korea tightens surveillance on high-risk implants with long-term tracking system

Korea is tightening oversight on high-risk implantable medical devices, introducing a long-term tracking system designed to prevent adverse events before they escalate. 

The Ministry of Food and Drug Safety (MFDS) announced Tuesday that it has amended regulations to strengthen post-market surveillance and improve patient safety.

The move follows a case of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) identified in the country three years ago.

The tracking system will designate high-risk implantable devices for monitoring, collecting real-world data from participating medical institutions. The data will include details on the surgical environment, adverse events, and patient health status related to implanted devices, enabling authorities to detect and respond to safety concerns early.

Among the devices subject to surveillance are artificial joints, breast implants, and implantable cardiac pacemakers. “Real-world evidence will allow us to take corrective actions before patient safety is compromised,” an MFDS official said.

Under the revised regulation, medical professionals must report serious adverse effects observed during device use directly to MFDS. The system also includes provisions for patient compensation through insurance or mutual aid in cases of harm. Additionally, manufacturers will face stricter post-market requirements, including re-evaluations, approval renewals, and inspections to ensure compliance with safety standards.

The decision to expand long-term monitoring stems from a 2019 case in which Allergan voluntarily recalled its BIOCELL textured breast implants and tissue expanders worldwide after concerns over BIA-ALCL. That case, along with growing scrutiny over implantable medical device safety, prompted Korea’s regulatory authorities to act.

Adverse events related to implantable medical devices have surged 152 percent over the past five years, driven largely by imported products, according to data from the MFDS. 

In 2019, there were 538 reports of adverse events. By 2023, that number had climbed to 1,357, with imported devices accounting for the sharpest increase—a 177.6 percent spike compared to a modest 5.1 percent rise for domestically manufactured products.

For the past three years, MFDS has conducted a pilot program evaluating long-term follow-up investigations on high-risk devices. With the results in hand, the agency is now finalizing guidelines for full-scale implementation. The regulation is set to take effect in August.