South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.

The announcements include:

  • Where COVID-19 self-test kits may be sold to be exempt from sales reporting.
  • How implantable medical device manufacturers must comply with patient compensation insurance requirements. Answers to common questions are in a new FAQ document.
  • Which institutions have been designated for non-clinical testing of medical devices…