Enable JFMDA Device Coding

With the 26R3 release, Veeva Safety supports the Japan Federation of Medical Devices Associations (JFMDA) Device Code dictionary for coding medical device information. Veeva updates Vault’s JFMDA Device Code Dictionary once a year in the spring, in line with the JFMDA release schedule.

Prerequisite

To enable this feature in your Vault, you must first enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.

To make device-related case processing more efficient, we recommend enabling Automatic Adverse Event Device Code Creation.

Overview

To enable this feature in your Vault:

• Configure object layouts
• Create the JFMDA Device Code Dictionary
• Display the JFMDA Device Code object in Business Admin
• Create a custom JFMDA sub-tab on the Dictionaries tab for the JFMDA Device Codes object
• Update the Case Entry Actions permission set

Configure Object Layouts

To configure object layouts:

• Copy the following standard object layouts:
  • JFMDA object type on the Dictionary object
  • Case Product Device Code
  • Localized Case Product Device Code
• Add the JMDN Code field to object layouts as follows:
  • On the Device object type on the Product object, below the Description of Device field
  • On the Product Registration object, below the Device Market Date field

Create the JFMDA Device Code Dictionary

To create the JFMDA Device Code Dictionary:

1. Navigate to Business Admin > Objects > Dictionaries.
2. Select Create.
3. In the Create Dictionary dialog, select JFMDA, then select Continue.
4. On the Create JFMDA page, enter JFMDA Device Code Dictionary in the Name field.
5. Update the Active JFMDA Version.
6. Select Save.

Update the Case Entry Actions Permission Set

To update the custom Case Entry Actions permission set, add View permissions to:

• The following control fields on the Case Product Device Code object:
  • Device Code
  • JFMDA Device Code
• The JFMDA Device Code control field on the Localized Case Product Device Code object