Requirements for Importing Research Use Only Medical Devices into Japan

J

jennaleeb

#1
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
 
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