6 Setting up reporting rules
The following table describes the types of auto scheduled reports based on the Device Reporting Category and Form as PMDA Device or Form 8 or Form 10 selected in the reporting rule configuration.
For the existing reporting rules which are configured for paper report Form 8 and Form 10, it is recommended that you review them and update the Device Reporting Category field with corresponding new value.
Note:
Since Device Reporting Category is a common field in reporting rule configuration, please ensure that you select the category only for the PMDA Device Form or Form 8 or Form 10.Device Reporting Category | Report scheduled |
---|---|
Domestic infection case report | Form 8 XML or Paper |
Domestic defect case report | Form 8 XML or Paper |
Foreign infection case report | Form 8 XML or Paper |
Foreign defect case report | Form 8 XML or Paper |
Medical device research /survey report | Form 10 XML or Paper |
Survey report of foreign safety measures | Form 10 XML or Paper |