South Korea - Proposed Amendments to the “Regulation on Medical Device Group and Class by Group”

​The Ministry of Food and Drug Safety (MFDS) is amending the “Regulation on Medical Device Group and Class by Group” as follows:

1) Establishment of new items - Establishment of five new medical device items to classify temporarily designated items.

2) Adjustment of the class of medical devices - One item was reclassified considering international harmonization and equity with other medical devices.

3) Modification of item definition (including clerical error) - The definitions of five medical device items were modified.