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Medical Device Classification on PMDA Device Report form (Doc ID 2133743.1)

Last updated on MARCH 25, 2019

Applies to:

Oracle Argus Safety Japan - Version 6.0.7 to 8.0.1 [Release 6.0 to 8.0]
Information in this document applies to any platform.


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  and form-10:

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?


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