Enable PMDA Medical Device and Regenerative Medicine Reporting: Data Model

With the 25R3 release, Vault introduces the data model to support capturing medical device and regenerative medicine product information for domestic Cases and Localized Cases for Japan. This update lays the foundation for future PMDA reporting functionality.

This feature is Auto-on, however, some components require additional configuration. After configuring this feature, see Set Up the Localized Business Admin Library for Japan and PMDA Case Field Reference for more information.

Configure Object Layouts

To support capturing device and regenerative medicine data, update the following object layouts:

• Product Registration
• Localized Study
• Case Product Registration
• Localized Case Product Device Code
• Localized Case Assessment Result
• Local Reporting Details

Update the Product Registration Layout

Add the following fields to the PMDA section of the Product Registration layout of the Product Registration object:

• Device/Product Generic Name
• JMDN Code
• Device Classification 1
• Device Classification 2
• Device Classification 3
• Regenerative Classification

Update the Localized Study Layout

Add the following fields to the PMDA section of the Localized Study Detail Page Layout of the Localized Study object:

• Dates of Clinical Trial Notification
• Primary Investigational Product Category
• Study Device Classification

Update the Case Product Registration Layout

To update the Case Product Registration Detail Page Layout of the Case Product Registration object:

1. Insert a Detail Form section:
   • Section Label: Enter Device/Regenerative.
   • Section Layout: Select Detail Form - Two Columns.
2. Add the following fields to the Device/Regenerative section:
   • Device/Product Generic Name
   • JMDN Code
   • Device/Product Details
   • Device Classification 1
   • Device Classification 2
   • Device Classification 3
   • Regenerative Classification
   • Device/Regenerative Usage Status
   • Device/Regenerative Usage Count
   • Device/Regenerative Usage Period
   • Device/Regenerative Usage Period (unit)
   • Device/Product Collection Status
   • Uncollected Status
   • Regenerative Conditional Approval

Update the Localized Case Product Device Code Layout

Add the following fields to the Details section of the Localized Case Product Device Code Detail Page Layout of the Localized Case Product Device Code object:

• Local Term
• Possible Patient Health Damage
• Expectedness
• Onset Date

Update the Localized Case Assessment Result Layout

Add the Source Causality Comments field to the Details section of the Localized Case Assessment Result Detail Page Layout of the Localized Case Assessment Result object.

Update the Local Reporting Details Layout

To update the Local Reporting Details Detail Page Layout of the Local Reporting Details object:

1. Insert a Detail Form section:
   • Section Label: Enter Device/Regenerative.
   • Section Layout: Select Detail Form - Two Columns.
2. Add the following fields to the Device/Regenerative section:
   • Device Case Expectedness
   • Device Event Date
   • Contact Person
   • Device Outcome
   • Device Outcome (other)
   • Patient Health Effect Status
   • Device Problem Status
   • Device Future Action Classification