Utility to Load JFMDA Dictionary into Argus (Enhancement 35450775)
(Doc ID 3036818.1)
Last updated on NOVEMBER 18, 2024
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.4 to 8.4.3 [Release 8.4]Oracle Life Sciences Argus Safety Japan Cloud Service - Version 8.4 to 8.4.3 [Release 8.4]
Information in this document applies to any platform.
Goal
JFMDA (Japan Federation of Medical Devices Associations) publishes the "Medical Device Defect Glossary" for coding medical devices (JMDN code, JMDN term, Terminology code) and device malfunctions (JFMDA code, JFMDA term and supporting data). JFMDA provides mapping between IMDRF (International Medical Device Regulators Forum) and JFMDA codes as part of the glossary.
Starting from Argus 8.4, the Pharmaceuticals and Medical Devices Agency (PMDA) Device XML reports and PMDA Device paper reports (Form 8, Form 10) reports are supported as out of the box features. Coding of medical device terms are performed using JFMDA dictionary loaded into Argus.
In Argus 8.4, the JFMDA version 4.0 is loaded as factory data.
In Argus 8.4.1, the JFMDA version 5.0 is loaded as factory data.
JFMDA version 6.0 is published on 12-Jan-2024. As per PMDA guidelines, at any point of time, it is allowed to use the latest version and the previous version.
Example: when JFMDA version 6.0 is released, PMDA accepts version 6.0 and version 5.0. The reports submitted using version 4.0 would be rejected.
JFMDA has communicated the ETA for version 7.0 as Sep-2024. This means, once version 7.0 is released, PMDA would only accept reports coded with version 6.0 or version 7.0.
It is recommended to use this utility to load the latest JFMDA version for all Argus Japan customers generating PMDA Device XML/Paper reports.
Solution
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In this Document
| Goal |
| Solution |
| References |