PMDA Device report updates

Summary

PMDA Device Form 8 & Form 10 enhancement (Enhancement 35634058, 35634389, 35634345, 36353330, 35963017,35633846, and 35634461)

Description

This release introduces enhancements to the PMDA Device XML Form 8 and Form 10 to align with regulatory compliance, and reporting accuracy for PMDA Device reporting.

• Pr.6 CONCOMITANT MEDICAL DEVICE from Free Text—To support more flexible and accurate data entry, a new free text field titled “Concomitant Device Comments” (併用医療機器コメント) has been introduced under Products tab > Device tab > Device Information section.
• Narrative generation is enabled for this field. Data entered in this field is transmitted in PMDA Device Form 8 and Form 10 element CONCOMITANTMEDICALDEVICE [Pr.6]
• Partial Date for Date of Event—Partial Dates like year (CCYY) or year & month (CCYYMM) entered in Argus J > Product tab > Device tab > PMDA Device Information (PMDA機器情報) section>Date the problem occurred (不具合発生日) field is transmitted in PMDA Device Form 8 and Form 10 element DATEOFEVENT [M.3]
• Custom Device Code list Flexibility—Console code lists for ‘Device Classification’ and ‘Device Outcome’ now support add/copy/delete functionalities for custom values, allowing better support for evolving medical technologies.
• Default Report View Configuration—Organizations can now set a default viewing format for PMDA Device Reports. Under Common Profile Switches > Argus J > Reporting > Device Report, a new option titled “Default viewing format of the PMDA Device Report” has been added in the section “File attachments allowed for PMDA Device Profile.” This allows you to configure the preferred format—XML, Decoded, or Paper View—for easier and consistent report viewing.
• Improved Patient Age in Decades representation—When patient age is captured in “decades” in the case form, it is converted and displayed in line with Japanese conventions for reporting in the elements NUMBEROFAGE[Pa.2.1] and UNITOFAGE[Pa.2.2]. For example: If the case form specifies “9 decades”, the report output will display “80 歳代” [In their 80s]
• BRANDNAME [Pr.1] Mapping Update for Combination Products—BRANDNAME [Pr.1] mapping for combination device products (PMDA Device Classification 1 "Combination product (drug)") is now updated to populate drug trade name based on the combination product definitions configured in the COMBO_PRODUCT_RELATIONSHIP flexible code list for Japan device license for which the report is scheduled.
• XML Filename Enhancement—The Argus case number is now included in the PMDA Device XML filename, making it easier for users to identify and manage report files.

  Existing: Alphanumeric D<hyphen>Sender's identifier (S.5)<hyphen>Report date(S.1)<hyphen>Unique file/sequence number.xml ( English alpha numeric)

  New Format: Alphanumeric D<hyphen>Sender's identifier (S.5)<hyphen>Report Generated Timestamp<hyphen> /case number and Two Capital Alphabetical Letters.xml

  Example: D-ryakumei-20200401000125-case1AA.xml

• Accurate Nullification Reporting—PMDA Device Nullification (cancellation) reports now pulls data from the most recently submitted report, rather than the current case data, as per regulatory requirement.
• Enhancements to Validation Messaging—Validation message for Approval Number [Pr.4] now specify that alphanumeric values are accepted for the Approval Number to align with the allowed format, preventing user confusion. Additionally, improved validation logic for optional PMDA Device data elements are provided to ensure compliance and reduce reporting errors when report is marked ‘Complete’.

For more information, refer to ArgusInterchange2026.1.01_PMDA Device Export Mappings.xlsx.