As part of the Korean government’s increased focus on the safety management of medical devices, the Ministry of Food and Drug Safety (MFDS) has released a draft of updated safety regulations in the fall of 2017. These changes include:
- For adverse events that have occurred overseas, manufacturers must also report events to the MFDS. Overseas adverse events must also be reported using the same timeline and guidelines as domestic adverse events.
- When reporting adverse events, the amount of safety information collected will be more detailed than before.
- A revision of a “serious adverse event (SAE)” to be defined as an “event in which death or a life-threatening adverse event has occurred”
- Updated requirements for timeline extensions for supplementary data submissions
The Korean ministry is requesting comments from key industry players, and will enforce the new regulations at a later date.