On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case.
The medical device safety information management system is briefly as follows.
1. If the medical device handler recognizes that death or serious side effects have occurred or are likely to occur while using the medical device, the medical device handler reports to the Minister of Food and Drug Safety.
2. NIDS requests submission of data for collection, analysis and evaluation of reported adverse events, and reports the analysis and evaluation results to the Ministry of Food and Drug Safety (Medical Device Safety Evaluation Division).
3. If an adverse event caused by a medical device causes death or poses a threat to life, it is immediately reported and the Ministry of Food and Drug Safety takes action such as providing safety information, recall, and suspension of manufacturing and sales operations according to the evaluation results.
< Subject to medical device adverse event report >
| Division | Report period | |
| 1 | If it causes death or life-threatening side effects | Report within 7days |
| 2 | When hospitalization or extension of hospitalization period is necessary | Report within 15days |
| 3 | If recovery is impossible or causes serious disability or functional decline | |
| 4 | If it causes congenital deformities or abnormalities | |
| 5 | Other important information and adverse events that do not fall under Article 51, Paragraph 1 of the Enforcement Rules | Report within 30days |
| 6 | Measures such as announcements from foreign governments | Report within 30days |
As such, the medical device adverse event report guidelines include procedures and methods for collecting, reporting, and taking action on safety information, including adverse events that occurred in connection with the use of medical devices.
Additionally, through this revision, examples of standard codes for frequently used medical device adverse events in the guideline [Appendix 5] have been added. Please refer to the attached file below for more information.