In Vitro Diagnostic Medical Devices

Proposed partial amendments to the "Regulation on In Vitro Diagnostic Medical Device Approval/Report/Review, etc.";; (23 page(s), in Korean)

The proposed amendments to the "Regulation on In Vitro Diagnostic Medical Device Approval/Report/Review, etc." are as follows:

A. Allow occasional reporting of minor matters of in vitro diagnostic medical devices and extend the quarterly reporting period.

B. After changing in vitro diagnostic medical devices, it was not possible to manufacture (import) the existing devices, but if the change was not due to side effects, manufacture (import) of the existing devices is allowed for six (6) months.