Dear Collegues,
I are trying to enter Japanese market with intraocular device, EU class IIb.
Our distirbutor in Japan told use, that registering this deivce would take more than 2 years and milions od dollars.
The distributor proposed, that we import lenses as "unapproved devices" which can be do under doctors licence for 1-3 pieces and using [FONT="]Yakkan Shomei . Acording to distributor all premium lenses in Japan are imported as unapproved medical devices and he is importing them like this for many years.
Is it legal to import medical devices to Japan like this? Should we ask for some record of legality?
My concern is how to we deal with complaints and reportable events should they occure?
We have been ask to do quite a similar thing in Mexico. The difeerence wa that our sales rep would have to carry lenses onborard of fligth between Europe and US, then give them to Mexican distributor in US who whou import them to Mexico using his medical licence traveling on land.
Does anyone have experience with these unapproved medical devices imports?
Thanks!
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