TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1199

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed amendments to the “Regulation on medical device group and class by group”

Objective

Protection of human health or safety (TBT)

Product Covered

 Medical Devices

Document Notification

Link to ePing

HSCODE

ICSCODE

11.180.10 - Aids and adaptation for moving

Keywords

Specific Regions

Description

The proposed amendments to the “Regulation on medical device group and class by group”  is as follows:1) Establishment of the technology levels of autonomous driving electric wheelchair_x000D_
- Establishment of new standards to create a basis for classifying autonomous driving electric wheelchairs, taking into account their place of use and technical functionalities such as location determination, map formation, route creation, etc.2) Establishment of new items_x000D_
- Establishment of 42 new items for medical devices to categorize those developed within the industry and formalize temporarily designated items3) Adjustment of the class of medical devices_x000D_
- The class of 8 items was adjusted considering international harmonization and equity with other medical devices.4) Change in item name (including English name) and definition._x000D_
  - Two item names or definitions were changed based on item subdivison and considerations regarding clinical use environments.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/KOR/1199

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