The current Act requires those who want to do business in manufacturing or importing medical devices to obtain manufacturing or import business permission and states that they should obtain manufacturing or import permission or certification or file a manufacturing or import notification for the medical devices they intend to manufacture or import, but exemptions from the foregoing are specified not in the Act but the Enforcement Rule thereof.

The problem is the subordinate Enforcement Rule, not the Act, specifies exemptions for manufacturing or import business permission, and manufacturing or import permission, certification, and notification even though these are matters related to the rights and obligations of those who manufacture or import medical devices for clinical trials, research, or their direct use.

In this regard, this Act aims to update the current legislation by directly specifying matters related to the medical devices which do not need to obtain manufacturing or import business permission or can be manufactured or imported without manufacturing or import permission, certification, and notification, and preparing the basis to impose penalties for any violation of the foregoing (Articles 6-4 and 15-2 newly inserted).

Require applicable medical devices to be used only for their intended purposes and impose penalties for any violation of the foregoing (Articles 6-4 and 15-2 newly inserted).