Medical Devices

Proposed amendments to the "Regulation on medical device group and class by group"; (32 page(s), in Korean)

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

- 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

- Establishment of 42 new items for medical devices to categorize those developed within the industry and formalize temporarily designated items

3) Adjustment of the class of medical devices

- 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.

- Two item names or definitions were changed based on item subdivison and considerations regarding clinical use environments.