The South Korea’s Ministry of Food and Drug Safety (MFDS) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting.
MFDS Notification No. 2014-91 and the MFDS website offer valuable information on terminology, timelines and other vigilance reporting requirements in South Korea.
Companies that fail to accurately report incidents to could face severe financial penalties or criminal sentences. Ignorance is not an acceptable excuse for not implementing a vigilance system for South Korea, so you must be proactive.
When Are Vigilance Reports Required in South Korea?
You or your Korean License Holder (KLH) should report adverse events to the MFDS. Adverse events occurring in South Korea must be reported if they lead or death, serious injury, or any of the following scenarios:
- hospitalization or an extension of hospitalization
- irreversible injury, serious disability and decrease of function
- congenital deformity or abnormality
If a recall is necessary, it must be classified as Class I, II or III (nothing to do with your device classification) based on severity and submitted with a recall plan to MFDS for review. The recall plan should also include a strategy for informing consumers about risks associated with the medical device. The Code for Patient and Medical Device Event shall be selected from the MFDS Notification, and document stating the reason of the recall should be submitted.
South Korea MFDS Vigilance Reporting Process
Shown below are the basic steps you should follow in reporting an adverse event with your medical device in South Korea:
- Inform your Korea License Holder and the Ministry of Food and Drug Safety (MFDS) that a reportable adverse event has occurred.
- Investigate the cause of the adverse event and report all findings to the MFDS.
- Determine recall classification, Patient Code, Medical Device Event Code, and inform MFDS.
- Report final outcomes of the adverse event investigation and corrective action to the MFDS.
- Add all reports, along with any correspondence with the MFDS to your Quality Management System records.
- Your KLH should include adverse events in annual reports submitted to MFDS.
Need help with vigilance reporting in South Korea?
We have established excellent relationships with MFDS officials and are very familiar with handling vigilance issues and incident reporting in South Korea.
Working with Emergo offers you the following benefits:
- If we act as your Korea License Holder, we can submit adverse event reports and recall information to the MFDS on your behalf.
- Our in-depth knowledge of Korean medical device regulations ensures that your vigilance procedures will always be up-to-date.
- Our experienced consultants can help you determine when incidents are reportable and ensure that reports required by the Korean MFDS are completed on time.
- We have experience assisting hundreds of manufacturers with post-market surveillance, MFDS registration and other regulatory consulting services.
Please contact us for more information on how we can assist you with medical device vigilance reporting for South Korea.