# Enable PMDA Medical Device and Regenerative Medicine Reporting

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 the following articles for more information: 

* <a href="/en/lr/1005170/">PMDA Medical Device & Regenerative Medicine Forms Overview</a>
* <a href="/en/lr/01194/">Set Up the Localized Business Admin Library for Japan</a>
* <a href="/en/lr/872016/">PMDA Case Field Reference</a>

## 26R1 Update: Japan Postmarket Device & Regenerative Reporting

With the 26R1 release, Veeva Safety supports the generation of PMDA's standard postmarket forms for adverse events related to medical devices and regenerative medicines, including forms 8, 10, 13, and 14. All forms are available in PDF and XML format. This feature also introduces additional fields for capturing and transmitting all of the required regional data. To configure your Vault for the updated feature, ensure your object layouts include all of the fields listed on this page.

## Configure Object Layouts

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

* [_Product Registration_][1]
* [_Localized Study_][2]
* [_Case Product Registration_][3]
* [_Localized Case Product Device Code_][4]
* [_Localized Case Assessment Result_][5]
* [_Local Reporting Details_][6]

### Update the Product Registration Layout {#pr-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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 {#ls-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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 {#cpr-layout}

To update the _Case Product Registration Detail Page Layout_ of the _Case Product Registration_ object: 

1. Insert a <a href="/en/lr/26387/#how-to-add-detail-forms">_Detail Form_ section</a>:
    * **Section Label**: Enter `Device/Regenerative`.
    * **Section Layout**: Select **Detail Form - Two Columns**.
2. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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 {#lcpdc-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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_
* _Defect Expected_
* _Defect Term_

### Update the Localized Case Assessment Result Layout {#lcar-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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 {#lrd-layout}

To update the _Local Reporting Details Detail Page Layout_ of the _Local Reporting Details_ object: 

1. Insert a <a href="/en/lr/26387/#how-to-add-detail-forms">_Detail Form_ section</a>:
    * **Section Label**: Enter `Device/Regenerative`.
    * **Section Layout**: Select **Detail Form - Two Columns**.
2. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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_
    * _Reference Number_
    * _Reference Number Year_
    * _Previous Reference Number_
    * _Previous Reference Number Year_

### Update the Localized Case Document Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the following fields to the _Details_ section of the _Localized Case Document Detail Page Layout_ of the _Localized Case Document_ object:

* _Measure Classification_
* _Measures Classification Details_

### Update the Localized Case Adverse Event Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Outcome (Other)_ field to the _Details_ section of the _Localized Case Adverse Event Detail Page Layout_ of the _Localized Case Adverse Event_ object.

[1]: #pr-layout
[2]: #ls-layout
[3]: #cpr-layout
[4]: #lcpdc-layout
[5]: #lcar-layout
[6]: #lrd-layout