The new regulations (after 25th Dec, 2014) can be summarized as follows.
License for selling high-controlled medical devices
License for selling healthcare devices
There is no license for general medical devices. Guidelines for general medical devise should be defined in compliance with medication or medical device related law or enforcement regulation of the same law.
The existing concept of “rental” is replaced by “lend”, which also includes the meaning of lending free.
License for lending business can be classified into the following two different types:
License for selling high-controlled medical devices
License for selling healthcare devices
There is no license for general medical devices. Guidelines for general medical devise should be defined in compliance with medication or medical device related law or enforcement regulation of the same law.
License is required for repairing medical devices.
License can be classified into two different types by repairing type or business place.