Medical Devices Manufacturing & Sale

The new regulations (after 25th Dec, 2014) can be summarized as follows.

License is required for manufacturing and selling medical devices or in-vitro diagnostic medical devices.
Manufacturing and selling medical devices and in-vitro diagnostic medical products can be classified into the following different types.
Device Type License
High-Controlled Class 1. License for manufacturing and selling medical devices.
Healthcare Class 2. License for manufacturing and selling medical devices.
General Class 3. License for manufacturing and selling medical devices.
In-Vitro Diagnosis Class 4. License for manufacturing and selling in-vitro diagnostic medical devices.
(Quoted from 2nd paragraph of article 23in pharmaceutical law on license for manufacturing and selling)
You should determine in which your product is included: medical device or in-vitro diagnosis medical device. If your product is a medical device, you should make sure that you product type belongs to which of the following: general, healthcare, or high-controlled.
License for manufacturing and selling medical devices/in-vitro diagnostic medical products is valid for 5 years.
New regulations, which have taken effect since 25th Dec, 2014, distinguish medical devices and in-vitro diagnostic medical devices from medicines.

※ Any programs used for diagnosis should be regulated by the new regulations.

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