Medical Devices Manufacturing

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

Domestic Manufacturing (Domestic Manufacturer)
Manufacturing license is required for manufacturing a product in Japan.
Manufacturing license is requiredfor storing product prior to consignment.
Manufacturing license is required for the OEM when the partial production is done by OEM.
Foreign Manufacturing (Foreign Manufacturer)
Manufacturing license is required when a product is imported.
Manufacturing environment may differ.
Product categorization may differ. The medical devices in overseas countries may not be eligible in Japan.