2 Introduction

MHLW has published the revised Paper format and the new XML format for Medical Device reports. Companies should send Medical Device reports in XML format effective from April 1st 2020 and mandatory from April 1st 2021. PMDA has published regulatory guidance for various documents, including Data element check lists, Check rules, and XML references.

Figure 2-1 Flow diagram for submitting a PMDA device XML and import ACK