South Korea - Amendment of the “Regulation on Medical Device Group and Class by Group”
Business description
South Korea Ministry of Food and Drug Safety announced the amendment of the “Regulation on medical device group and class by group” to promoting the health and safety of medical professionals and improving the management of medical devices.
The main changes proposed are:
1) ‘Respirator, medical’ as medical device was newly classified
2) The number of software as medical devices were expanded from 8 to 90 considering clinical field
Proposed date of adoption : To be determined
Proposed date of entry into force : To be determined
Final date for comments : 09/16/2020
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