Including ISO 13485 Audit JPAL Registration

K

kcollins

#1
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!
 
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medic61

Involved In Discussions
#3
After expericing two JPAL audits (sent by our customers), 5 years apart we are now asked by our customers in Japan for our latest notified body audit report.
1. I only send it to the Notified Body, usually JET or SGS.
2. I will redact anything that is company confidential.
Good Luck!
 

pittmatj

Involved In Discussions
#4
On a similar note, my company was looking to register with a new distributor in Japan for our Class I Devices. They wanted all of our QA manufacturing reports and test data, most of which was confidential. We never provided anything like this before for a country submission (not even previously in Japan). The registrar said they needed it in case of an audit of their company by JPAL, which they would be required to produce these documents within 48 hours.
 
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