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PMDA Device E-submission Regulations (Doc ID 2657781.1)

Last updated on DECEMBER 04, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Goal

PMDA has a new regulation to submit device reporting via e-submission by Apr 2021. This will entail using a new format.
What is Oracle's Argus Safety response to this?
 

Solution

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In this Document
Goal
Solution
References


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