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