In South Korea, post-market surveillance (PMS) is a critical component of medical device regulation. The Ministry of Food and Drug Safety (MFDS) enforces stringent requirements to ensure the continued safety and performance of medical devices once they are on the market. This article outlines the South Korea post-market surveillance medical devices framework, including MFDS vigilance reporting, adverse event reporting in Korea, and field safety corrective actions (FSCA)—and how OMC Medical can assist with compliance through its local presence in South Korea.
What is Post-Market Surveillance in South Korea?
Post-market surveillance in South Korea refers to the set of activities mandated by the MFDS to monitor the safety, efficacy, and quality of medical devices after they have been approved and made available on the market. These activities are primarily governed under the Medical Devices Act and its related enforcement rules.
Manufacturers, importers, and distributors must implement robust surveillance systems to track real-world device performance and report any adverse incidents.
Who Must Comply with PMS Requirements?
Expand on the types of entities responsible—not just manufacturers and importers, but also:
- Authorized Representatives (for foreign companies)
- Distributors and third-party logistics providers
- Korean testing labs (if involved in PMS studies)
MFDS Vigilance Reporting System
The MFDS vigilance reporting framework is built around proactive identification and communication of safety issues. Key stakeholders—including manufacturers and importers—must report any incidents or risks associated with medical devices to the MFDS.
Mandatory Reporting Includes:
- Device malfunctions that could lead to patient harm
- Deterioration in device performance
- Labeling errors
- Biological or chemical contamination
Reports must be submitted via the MFDS Medical Device Information System (MDIS). Timelines for reporting vary depending on the severity of the incident:
- Serious adverse events: Within 7 days
- Non-serious events: Within 15 days
Adverse Event Reporting in Korea
Adverse event reporting in Korea is a central obligation under PMS regulations. An adverse event includes any unintended, harmful occurrence associated with the use of a medical device.
Responsibilities Include:
- Continuous monitoring of device usage
- Collecting user and healthcare provider feedback
- Submitting follow-up reports if new information becomes available
Failure to report adverse events may result in administrative penalties, product recalls, or suspension of device licenses.
Field Safety Corrective Action Korea
When safety issues are identified, the MFDS may require a field safety corrective action (FSCA) in Korea. This involves urgent and strategic measures taken to reduce risk, such as:
- Device recalls
- Software corrections
- Replacement or modification of affected devices
Manufacturers must submit a Field Safety Notice (FSN) detailing the corrective action, risk assessment, and communication strategy to affected users. The FSN must be pre-approved by the MFDS before implementation.
How OMC Can Help?
OMC Medical, with a local presence in South Korea, provides expert support for companies navigating the complex PMS and vigilance requirements.
OMC Medical can help with:
- Preparing and submitting MFDS vigilance reports
- Conducting local post-market surveillance activities
- Managing adverse event and FSCA communications
- Ensuring Korean language compliance for FSNs and reports
- Liaising directly with MFDS authorities
Having a reliable partner like OMC Medical ensures that your medical devices remain compliant with South Korea post-market surveillance medical devices regulations throughout their lifecycle.
Conclusion
Staying compliant with MFDS vigilance reporting, adverse event reporting in Korea, and field safety corrective actions in Korea is vital for any medical device company operating in the region. With ever-evolving regulations and strict enforcement, partnering with a local expert like OMC Medical streamlines compliance and ensures patient safety.
Contact OMC Medical today to safeguard your products and register your medical devices in South Korea.
