Load Device components

It is recommended that code list values are loaded within the Device Sub Component Code list based on Annex G provided by IMDRF (International Medical Device Regulators Forum).

Device_Subcomponents Codelist can be loaded from back end using Annexure G provided by IMDRF.

Annexure G must be loaded to Device Sub Component Code list considering the following column mappings between Annexure G provided by IMDRF, and Device Sub Component Code list in Oracle Argus Safety.

• Loading of Device Components: Standard codelist LM_DEVICE_SUBCOMPONENT. SUBCOMPONENT_NAME is updated via backend with Term (Level1, Level2 and Level3)
• Loading of IMDRF Codes: Flex codelist CODE_LIST_DETAIL_DISCRETE.DISPLAY_VALUE is updated with IMDRF codes for the decode context IMDRF_CODE as provided in Annex G
• Loading of Definition: Flex codelist CODE_LIST_DETAIL_DISCRETE.DISPLAY_VALUE is updated with Definition for the decode context DEFINITION E as provided in Annex G

Note:

Harmonized Codes with IMDRF & FDA Codes for Annexures A, B, C, and D and Annexures E and F with IMDRF Codes are pre-loaded in the new repository.