# PMDA Medical Device & Regenerative Medicine Forms Overview

Vault supports mapping _Case_ details to the standard postmarket forms for reporting adverse events related to medical device and regenerative medicine products to the PMDA. Vault formats forms as either a PDF or XML file based on the _Transmission Document Type_ of the associated _Transmission_.

Review the following articles to learn how Vault maps information to generate compliant forms:

* <a href="/en/gr/1005171/">PMDA Form 8 Mapping</a>
* <a href="/en/gr/1005172/">PMDA Form 10 Mapping</a>
* <a href="/en/gr/1005173/">PMDA Form 13 Mapping</a>
* <a href="/en/gr/1005174/">PMDA Form 14 Mapping</a>

## Prerequisite

Your Admin must <a href="/en/gr/934270/">enable PMDA Medical Device and Regenerative Medicine Reporting</a>.

## R.2 Attachments Section

For all postmarket medical device and regenerative medicine forms, Vault generates the R.2 Attachments section when applicable. Vault encodes _Case_ attachments with the _Case > Source > Attachment_ document type and the _Retransmit_ field set to _Yes_. Vault does not encode documents with the _Retransmit_ field set to _No_ or blank.

Vault may <a href="/en/gr/826501/#attach-incl-control">exclude attachment contents</a> on _Transmissions_ for domestic _Cases_ or _Localized Cases_ with previous _Transmissions_ that included the attachment to the same reporting destination.