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) intends to amend the “Regulation on medical device group and class by group” to include the following:
1) Establishment of new items
- Establishment of two new items for medical devices to categorize the formalize temporarily designated items.
2) Adjustment of the class of medical device
- One item is adjusted considering international harmonization and equity with other medical devices.
3) Change in item name(including English name) and definition(including typo)
- 13 item names or definitions are changed based on overhaul of terminology related to the disabled and the expansion of non-sterile products.
Source: G/TBT/N/KOR/1254
Countries:
South Korea
Technical aspects:
Certification / Approval / Test Mark
Safety
Business fields:
P.05 Medical
Regions:
Asia
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