The Medical device is used by medical professional to operate or to administer a drug on a patient under safety and controlled conditions in compliance to the medical authority regulations. The medical devices are promoted into the market for a specific purpose to be used as a combination with drug or independently after validating all safety trials and thorough research. The PMDA and MHLW Authority, Japan proposes a protocol to the manufactures and importers of the medical devices to report the adverse event (incident) experienced by a patient particularly due to a device in device drug combination treatments.
These reports are submitted by an authorized signatory who has investigated and captured the event, patients, preventive actions and device information.
Based on the identifying the suspect product, the MHLW Medical Device report is classified into two forms/templates, Form 8 and Form 10, respectively.
Form 8 (Medical Device Incident/Infection Case Report) – Contains information about the incident reported when the most suspected product is a medical device (product).
Form 10
(Medical Device Incident Research /Measures-taken Report) – Contains
information about the incident when the most suspect product is a
drug (E2B(R2) fields). It also contains information about the source
of investigation/ research.
Eg. details of Journal.
You may generate this report when the AER is open. The MHLW Medical Device Incident menu is available under the Report menu only when an AER is open. Also, you can generate the report from QBE and Workflow window. For more information on generating the report, refer section Generating Medical Device Incident Report.
Use any of the following options to generate the Report:
For an Open Case - Click Reports > Expedited > MHLW Medical Device Report from the main menu.
Select a Case in Workflow - Click Regulatory Report > MHLW Medical Device Report from the "Report" drop-down menu present in the Workflow Status screen.
In the QBE > List of Selected AERs window, click Regulatory Report > MHLW Medical Device Report.
The MHLW Report Selection Report window appears.
The report selection criteria window consist of the following tabs:
Sender
Receiver
Person in Charge
To generate the MHLW report.
From the Contact Name drop-down list, select the contact to whom you want to distribute the report.
All the distribution contacts having the Authority as MHLW Japan are displayed in this drop-down list.
Select the required contact.
In the Sender and Receiver tabs, all the information about the person who is sending and recipient of the report must be entered.
In the Person Incharge tab, enter the information about the person incharge in the regulatory authority to whom the report is addressed.
Based on the Drug-Device combination of the product criteria causing the adverse reaction, the application generates the following respective reports:
Form-8 report is generated if the AER is caused due to a device.
Form-10 report is generated for Device Research report and Device Measures taken report type for event or incident caused by medical devices.
NOTE: Medical Device Incident Report requires at least one AER to be active and the AER should have at least one Medical Device record.