Requirements for Importing Research Use Only Medical Devices into Japan

Hi there! We have an EU Class I (Canada and USA Class II) device which a researcher would like to use in an upcoming clinical trial. The first phase is just a focus group (not actually using the device) and the second phase they would be.

What are the requirements for importing this device to Japan if it is labelled research use/investigational testing use only?

Thanks!

Jenna

A Quick Bump!

Can someone help??

Thank you very much!