South Korea Medical Device Vigilance Reporting and Safety Monitoring

Regulatory Oversight of the MFDS

Regulatory Oversight of the EU Medical Device

The monitoring of medical device safety in South Korea is governed by the Ministry of Food and Drug Safety, commonly referred to as the MFDS. Manufacturers must comply with a vigilance system designed for post-market monitoring and adverse event reporting. Companies that fail to accurately report incidents could face severe financial penalties or even criminal sentences. Because Korean authorities do not accept ignorance as an excuse for failing to implement a vigilance system, manufacturers must remain proactive in their compliance efforts.

Criteria for Reporting Adverse Events

Adverse events occurring in South Korea must be reported to the MFDS if they lead to specific clinical outcomes or serious scenarios. Either the manufacturer or their Korean License Holder (KLH) is responsible for this notification.

• Incidents resulting in death or serious injury must be disclosed.
• Scenarios involving hospitalization or an extension of hospitalization require reporting.
• Irreversible injury, serious disability, or a decrease of body function must be reported.
• Any congenital deformity or abnormality associated with the device must be notified.

If a recall is necessary, it must be classified as Class I, II, or III based on its severity, regardless of the original device classification.

Administrative Vigilance Reporting Process

The management of safety issues follows a structured sequence of actions to ensure the MFDS is informed of both the incident and the corrective response.

Notification and Investigation

The reporting process begins by informing the Korean License Holder and the MFDS that a reportable adverse event has occurred. Manufacturers must then investigate the cause of the event and report all findings to the MFDS. If a recall is required, a recall plan must be submitted to the MFDS for review, including a strategy for informing consumers about associated risks and a document stating the reason for the recall.

Final Action and Documentation

Upon completion of the investigation, the final outcomes and corrective actions must be reported to the MFDS. All reports, along with any correspondence with the MFDS, must be added to the company's Quality Management System records. Furthermore, the KLH is responsible for including adverse events in annual reports submitted to the authority.

Role of the Korean License Holder

For international manufacturers, the KLH serves as the essential regulatory liaison in South Korea. The KLH is responsible for submitting adverse event reports and recall information to the MFDS on behalf of the manufacturer. They also ensure that vigilance procedures remain up to date with the latest Korean medical device regulations, such as MFDS Notification No. 2017-82.

Proregulations' South Korea Vigilance Services

Our team facilitates compliance with MFDS post-market requirements through the following specialized service modules.

• Korean License Holder and MFDS representation
  We act as your officially designated KLH to manage mandatory safety notifications and serve as the primary contact for all communications with the MFDS.
• Incident reportability and assessment support
  Our experts help determine when incidents meet the reporting criteria and ensure that the required reports are completed and submitted to the MFDS on time.
• Recall strategy and classification analysis
  We assist in determining the correct recall classification (Class I, II, or III) and developing the necessary recall plans and consumer notification strategies.
• Regulatory monitoring and MFDS website alignment
  Our consultants keep your vigilance protocols updated according to the latest MFDS notifications and website updates regarding terminology and timelines.
• Quality system integration and record maintenance
  We ensure that all final safety reports and vigilance correspondence are properly recorded within your technical files to satisfy regulatory audit requirements.

If you are interested in our South Korea medical device vigilance services and wish to maintain your market standing, please feel free to contact us.