Code Medical Device Information with JFMDA

To code medical device information reportable to the PMDA, Vault maps IMDRF codes to the corresponding Japan Federation of Medical Devices Associations (JFMDA) codes, ensuring accuracy when processing devices related to Japan domestic Cases and foreign Localized Cases. When you select an IMDRF or JFMDA code on a Japan domestic Case Product Device Code, Vault populates the corresponding IMDRF and JFMDA field values to the related foreign Localized Case Product Device Code. Vault also populates or updates these field values whenever you create or update a Case Product Device Code.

Prerequisites

To code JFMDA device data, your Admin must:

• Enable JFMDA Device Coding
• Manage the JFMDA Device Code Dictionary

Code a Japanese Device

You can initiate device coding from a Japan domestic Device-type Case Product by selecting a code depending on the available device data. You can select:

• An IMDRF code
• A JFMDA code

If needed, you can:

• Select Clear Selection to remove all IMDRF and JFMDA device code details from both the Case Product Device Code and the related Localized Case Product Device Code
• Recode mismatched IMDRF-JFMDA mappings
• Update JFMDA codes from a Localized Case Product Device Code

Select an IMDRF Code

To code a device using an IMDRF code:

1. Navigate to the relevant Case and expand the Device Codes section.
2. Select the relevant Case Product Device Code.
3. Select Edit.
4. Select an IMDRF Device Code Type.
5. Select an IMDRF Device Code.
6. Select the relevant JFMDA Level 1, Level 2, and Level 3 codes, as applicable. Vault filters these options depending on the populated JFMDA Device Code.

Upon selecting the IMDRF Device Code, Vault populates the corresponding JFMDA Device Code Type and any relevant JFMDA Level 1 through Level 3 codes, as applicable. If the selected IMDRF code corresponds to multiple JFMDA codes, Vault populates only the JFMDA Device Code Type and filters the available options for the JFMDA Level 1 through Level 3 fields accordingly.

Upon saving the Case Product Device Code, Vault maps the selected JFMDA field values to the related foreign Localized Case Product Device Code and populates the JFMDA Device Code Status accordingly.

Select a JFMDA Code

To code a device using a JFMDA code:

1. Navigate to the relevant Case and expand the Device Codes section.
2. Select the relevant Case Product Device Code.
3. Select Edit.
4. Select a JFMDA Device Code Type. Vault filters the available JFMDA Device Code Type options based on the JMDN Code on the related Product Registration or Product.
5. Select the relevant JFMDA Level 1, Level 2, and Level 3 codes, as applicable.

Upon selecting the most specific JFMDA Level 1 through Level 3 code for the device, Vault populates the corresponding IMDRF Device Code Type and Device Code.

Upon saving the Case Product Device Code, Vault populates the selected JFMDA field values on the related foreign Localized Case Product Device Code and populates the JFMDA Device Code Status accordingly.

Recode Mismatched IMDRF-JFMDA Mappings

When the IMDRF and JFMDA codes on a domestic Case Product Device Code do not map to one another or when either maps to a deprecated code, Vault displays a RECODE () tag next to the relevant IMDRF or JFMDA code field. When this occurs, you can recode the Case Product Device Code and its related Localized Case Product Device Code.

From the domestic Case Product Device Code, enter edit mode, then select a recoding option based on the cause of the mismatch:

• If the recoding issue is due to mismatched codes, select Update Mapping.
• If the recoding issue is due to a deprecated code, select Clear Selection, then code the correct code.

Update a JFMDA Code From a Foreign Localized Case

To update a JFMDA device code from a Japan foreign Localized Case:

1. Navigate to the relevant Localized Case and expand the Localized Case Product Device Codes section.
2. Select the relevant Localized Case Product Device Code.
3. Select Edit.
4. Select the relevant JFMDA Level 1, Level 2, and Level 3 codes, as applicable.
5. Select Save.

Upon saving the Localized Case Product Device Code, Vault maps the selected JFMDA field values to the related domestic Case Product Device Code and populates the JFMDA Device Code Status accordingly.