Editing the Product Identification Details

You can edit the details of a product identification. You cannot edit the details if the ASPI is in the Review state.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

  1. View the Properties of the ASPI. For more information, see Properties of a Product Identification.
  2. From the page toolbar, click Edit .
  3. Enter these details:

    Field Name Description
    Class Select the class. You can select one of the following options:
    • Class I
    • Class II
    • Class III
    Human Cell, Tissue or Cellular or Tissue-Based Product Select Yes if the ASPI is created using the human cell, tissue. Otherwise No.
    Animal Tissue Select Yes if the ASPI is created using the animal tissues. Otherwise No
    Device Exempt from Premarket Submission Select Yes if the ASPI is exempted from the premarket submission or conformity assessment. Otherwise No.
    Medical Purpose Enter the medical purpose for which the ASPI is created.
    Authorized Representative Click to search for and select the contact for which the type is added as Authorized Representative.
    Related ASPI Click to search for and select the related ASPI. The search results list the ASPIs that are created from the same country or region of the context ASPI.
    Kit Select Yes if the kit is used. Otherwise No.
    Combination Product Select Yes if the combination used to create the ASPI. Otherwise No.
    Issuing Agency Select the issuing agency. You can select one of the following options:
    • GS1
    • HIBCC
    • ICCBBA
    DI Number Enter the DI number.
    Device Type Selct the type of device. You can select one of the following options:
    • Medical Device
    • In Vitro Diagnostics
    • System
    • Procedure Pack
    Applicable Legislation Select the legislation that is applicable for the device. You can select one of the following options:
    • MDR
    • IVDR
    Special Device Select the device that is created for the special purpose.
    Device Applicability Select the device that is applicable for the usage.You can select one of the following options:
    • Software
    • Standard Soft Contact Lenses
    • Rigid Gas Permeable
    • Orthopedic
    Declaration Of Conformity Click to search for and select a document about the declaration of conformity.
    Note: If the declaration of conformity is connected to the context ASPI, then it need to be in the Released state to promote the ASPI to the Approved state.
    Summary of Safety and Clinical Performance Click to search for and select a document, which provides the summary of the safety and clinical performance of the device.
    URL Enter the URL releted to the safety and clinical performance of the device. By default, this option is disabled. When you add the document for the summary of the safety and clinical performance, also enter the URL details.

  4. Click Done.