With the 26R2 release, Veeva Safety supports the Japan Federation of Medical Devices Associations (JFMDA) Device Code dictionary for coding Japanese 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.

Overview

To enable this feature in your Vault:

Configure the JFMDA Dictionary Object Layout

To configure the JFMDA layout on the Dictionary object, copy the standard layout and ensure it is active.

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.

Display the JFMDA Device Code Object in Business Admin

To display the JFMDA Device Code object in Business Admin:

  1. Navigate to Admin > Configuration > Objects > JFMDA Device Code.
  2. Select Edit.
  3. In the Options section, select the Display in Business Admin checkbox.
  4. Select Save.

Create the JFMDA Sub-Tab

Create the JFMDA sub-tab on the Dictionaries tab as follows:

  • Label: Enter JFMDA
  • Tab Type: Select Object
  • Object: Select JFMDA Device Codes
  • Creation Options: Select Create record in new page