Looking for some guidance regarding JPAL registration in Japan: We are working with a distributor to register our class II medical devices in Japan and they (distributor working with Japanese consultant) are telling us if we include our latest ISO audit report as part of the registration process we can avoid the need of having a JPAL site inspection (providing a copy of our ISO cert is not sufficient enough according to our distributor). Has anyone had a similar experience? I've discussed this request with fellow RA/QA colleagues and we're all apprehensive about submitting our audit report because none of us know anyone who's dealt with this type of request. There's nothing of concern in the audit report, it's really more about the precedent of providing agency audit reports to other foreign countries. Thanks for any feedback!