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How To Submit The Nullification Report For PMDA Device Form-10 (Doc ID 2945578.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.4 and later
Information in this document applies to any platform.

Goal

PMDA does not accept the nullification of PMDA Device Form-10 reports in XML format but in paper format.

What is the way we should follow to submit the nullification of Form 10 report in paper format since the codelist: Reporting Destination setup is done only for XML reporting to PMDA and Initial report of Form-10 is an XML file and not the paper report?

 

Solution

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In this Document
Goal
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