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


Solution

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