Configuration updates in Argus Console

Device Reporting Category

The old factory data for the Device Reporting Category values are updated to set the Display value to No. It is recommended that you do not modify the display settings since the old values are no longer accepted by PMDA.

Device Reporting Category	Device Reporting Category (J)	Display
Infection Report	感染症報告	No
Malfunction with health damage	副作用報告	No
Malfunction without health damage	不具合報告	No
Measures in Foreign Country Report	外国措置報告	No
Research Report	研究報告	No

Common Profile Switches

A new common profile switch, File attachments allowed for PMDA Device Profile, introduced in System Configuration > Common Profile Switches > Argus J > Reporting > Device Report, has the following types populated by default:

PDF
JPEG
JPG
BMP
PNG
GIF
TIF
TIFF
RTF
TXT
XLS
XLSX
DOC
DOCX
XML
DICOM
HTML

Note:

It is recommended to review the supported attachment formats and remove formats that are not required as per the business need.

However, Argus does not support uploading HTM or HTML file types. It is recommended that you do not upload/attach HTM/HTML files.

PMDA Device Profile

Listed below you can find the best practices for configuring a PMDA Device Profile:

The standard device profile, PMDA-DEVICE MESSAGE TEMPLATE, uses a similar framework as the E2B(R3) profile.
Based on the reporting category selected in case form, either Form 8 or Form 10 XML is generated.
You can customize the transmit logic for each of the elements by copying the profile and changing the SQL query similar to E2B(R3) profile. Since the profile is common for Form 8 and Form 10 report, the customization logic caters to both report forms.
For example: If you update the logic for element DOCUMENT for compression logic, the compression logic is applied to both Form 8 and Form 10 reports attachments.
Since most of the data elements with respect to Form 8 and Form 10 device XML are same, the profile has elements related to both Form 8 and Form 10 XML reports. To distinguish elements specific to Form 8 and Form 10, elements are pre-fixed with the F8 and F10 tags, as shown in the screenshot below:

Figure 4-1 Manage Profile

Product Configuration

PMDA has published the Medical Device Defect glossary containing the JMDN and JFMDA details. The JFMDA codes are mapped to IMDRF codes. The glossary is loaded as factory data into the Oracle Argus database.

It is recommended that you do not update the glossary from the backend.

To configure a product, go to Console > Business Configuration > Product. Below you can find the recommended best practices:

The device generic name, along with the corresponding JMDN code and terminology code can be configured in the J Data Entry pop-up window. To access it, select the device from the Look up window which lists the JMDN glossary loaded into Argus system.
You can manually type the device generic name, if the device is not currently part of glossary. Allowing manual entry is implemented based on the feedback from customers. The Oracle Argus system directly transmits whatever is configured in Argus Console. However, PMDA has a validation check for the generic name and JMDN code to be part of glossary. So, if you are manually entering these fields, it is recommended that you work with PMDA to accept the generic name and JMDN code.
If the terminology code is not assigned for any of the selected or entered device generic name, then you can use the Z01 code for common terms.
If the product being configured is purely a device product (not a combination product), the device generic name you select in the J Data Entry pop-up window can be configured as a Generic name for the product

Figure 4-2 Product Configuration