Off-Label Use of a Medical Device in Japan

[shimonv]

Here is an interesting one...

A physician from Japan is interested to buy a medical device which is not cleared in Japan. Most probably it will be used for research & trials. Any tips on how the manufacturer can cover himself from liability and what to declare for the customs?

Would be nice to hear of similar experiences in other markets as well.


Thanks.
Shimon

 

[Jean_B]

It's been a while since I've dabbled in Japanese imports, but there are controlled exemptions to full registration for the traditional pre-market investigations, but also for private use in urgent cases without approved viable alternatives under the responsibility of a licensed physician.

You can find these in the law themselves, but to be honest I'd have the physician take the lead on the method from there. Note that private use is at the name level (patient or doctor). Not intended for selling on, etc.

 

[shimonv]

Interesting... thank you!