South Korea - Proposed Amendments to the “Regulation on Medical Device Group and Class by Group”
Business description
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.
Source: G/TBT/N/KOR/1339
Countries:
South Korea
Product categories:
05 Medical Devices
Technical aspects:
Safety
Business fields:
P.05 Medical
Regions:
Asia
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