PMDA Device XML reports

The PMDA Device XML report is handled in the same way as the existing E2B(R3) report framework. The following features are similar to E2B reports:

• Report Scheduling(Initial/ Follow-up/ Downgrade/Nullification)
• Report Generation (Initial/ Follow-up/ Downgrade/Nullification)
• PMDA Device Viewer
• Report Tracking
• Report Transmission
• Report Submission

When a report is scheduled by selecting the PMDA device as the reporting form, the PMDA device report is generated in XML format. Based on the selected Device Reporting category, either Form 8 XML or Form 10 XML is generated.

Note:

Both XMLs have the same profile: PMDA-DEVICE MESSAGE TEMPLATE.

Each device from the case is scheduled as separate Form 8 XML or Form 10 XML report, that is, if the case has two devices, two separate reports are scheduled.

Device reporting category	Device reporting category (J)	XML
Domestic infection case report	感染症症例報告（国内）	Form 8
Domestic defect case report	不具合症例報告（国内）	Form 8
Foreign infection case report	感染症症例報告（外国）	Form 8
Foreign defect case report	不具合症例報告（外国）	Form 8
Medical device research report/survey report	研究報告調査報告	Form 10
Survey report of foreign safety measures	外国措置調査報告	Form 10

The PMDA Device XML and Forms are handled as follows:

• When using the following signs: <, > and &, the <, > and & signs are converted in XML to '&lt;', ‘&gt;’ and ‘&amp;’.
• If the data type is Number, the following characters are permitted: 0-9, ‘.’, + or –.
• If the data type is text, then Kanji, hiragana, katakana, alphanumerics, Greek letters, special symbols and spaces can be used.

About manually scheduling a nullification report

To manually schedule a nullification report, click on the Report Status icon of the submitted PMDA Device report and select Schedule Nullification.

About auto-scheduling a nullification report

There are two ways to auto-schedule a nullification report for PMDA Device XML, as explained below.

When a case is deleted, the application auto-schedules the nullification if the case has submitted the PMDA device report. If the case does not have any selected value in the Nullification Reason field, then:

• その他 (Other) is populated in ReportWithdrawalReason.
• The justification provided by the user during the case deletion is populated in ReportWithdrawalReasonDetail.

If there is an existing submitted PMDA Device report (non-nullification report) and if there is a value selected in the Nullification Reason field for the same device, the application auto-schedules the next report as a nullification report.

Note:

The next report is not auto-scheduled until the Nullification Reason is cleared in the Case Form, even if there are new follow-ups added to the case because the nullification on top of the nullification is not supported. The application does not allow to manual or to auto-schedule 2 subsequent nullification reports.