South Korea Post-Market Surveillance (PMS): Tracking, Vigilance, and Penalties

South Korea Post-Market Surveillance (PMS) Requirements

The Ministry of Food and Drug Safety (MFDS) in South Korea enforces stringent Post-Market Surveillance (PMS) requirements to monitor the safety and effectiveness of medical devices after they enter the market. These regulations are detailed in the Medical Device Act.

Devices Subject to Tracking

Chapter V, Article 29 of the Medical Device Act specifies that certain high-risk devices are Subject to Tracking and require continuous monitoring:

• Medical devices that are inserted into the human body for one year or more.
• Life-supporting medical devices used in locations outside of medical institutions.
• Other devices identified by the Prime Minister.

Manufacturers, importers, and distributors of these devices must prepare and retain detailed records, including:

• Records of manufacture and sale (including price), lease, and repair.
• Records that enable the tracking of the subject using the medical device.

Adverse Event Reporting (Vigilance)

Manufacturers or importers are legally obligated to report adverse events to the MFDS.

• Reportable Events: Any occurrence or likelihood of death or a serious side effect resulting from the use of the device must be reported.
• Consequence: In the event of a reportable adverse event, the device becomes subject to recall.

Compliance and Sanctions

The MFDS, in conjunction with regional authorities, appoints Medical Device Surveillance Officers to enforce PMS through monitoring, sampling, and inspection (Article 33).

Failure to comply with all applicable regulations can result in severe administrative sanctions, including:

• Recall or destruction of the medical device.
• Corrective orders.
• Public notification.
• Revocation of approval (license revocation).
• Suspension of business activities.
• Administrative sanction fines of up to 50 million Won (approximately USD 45,400).