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Argus Safety - CDRH Revised Guidance in May 2020 for eMDR Submissions (Doc ID 2712826.1)

Last updated on OCTOBER 14, 2020

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.
14-Oct-20: added country ‘PALESTINIAN TERRITORY, OCCUPIED’

Goal

The purpose of this document is to provide a workaround for the latest regulation updates published in May 2020 by the Center for Devices and Radiological Health (CDRH).

Effective from May 2020, AS-2 submitters should not send ISO 3166 country codes, but are expected to send GENC3 codes.

These requirements are logged as an Argus enhancement request 31836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May202031836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May2020 .

 

Solution

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In this Document
Goal
Solution
References

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