The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience

Health Policy. 2021 Jul;125(7):941-946. doi: 10.1016/j.healthpol.2021.04.017. Epub 2021 May 4.


Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.

Keywords: Medical devices; Research design; Safety management.

MeSH terms

  • Equipment Safety
  • Humans
  • Product Surveillance, Postmarketing*
  • Republic of Korea