Medical Device Classification on PMDA Device Report form

(Doc ID 2133743.1)

Last updated on JANUARY 06, 2017

Applies to:

Oracle Argus Safety Japan - Version 6.0.7 and later
Information in this document applies to any platform.

Goal

According to the PMDA regulation, there are 9 categories in the "Medical Device Classification(医療機器の分類)".

Sample format:

PMDA Device Report form-8  : http://www.pmda.go.jp/files/000203279.pdf

PMDA Device Report form-10: http://www.pmda.go.jp/files/000203286.pdf



However, only 3 options are currently listed in the "PMDA Device classification1" field under Argus Console > business configuration > Products and license > License.


Is there any way to output the value other than 3 selections in the PMDA Device report form-8/10?

Solution

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