Creating a Product Identification

You can create a product identification for the product across all the countries or regions.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

  1. View the list of product identifications. For more information, see Product Identifications.
  2. In the page toolbar, click the Edit .
  3. In the Edit mode, click the Insert Above or Insert Below.
    The new row is added.
  4. Enter these details:

    Column Name Description
    Name Enter the name of the product identification (ASPI.
    Revision Enter the revision number foe the ASPI.
    Region Click to search for and select a region of the ASPI.
    Country Click to search for and select a country of the ASPI.
    Class When you select a country or region, the Class is selected.
    Device Identification The device identification (DI) that is connected with the country or region is selected.
    Note: If the DI is not connected with the country or region, select the values as Yes or No.
    Authorized Representative Click to search for and select a person that is added as authority to the ASPI.
    Device Exempt from Premarket Submission or Conformity Assessment Select Yes to exempt the ASPI from the premarket submission or conformity assessment. Otherwise select No.
    Owner Enter the owner details.
    Medical Purpose Enter the details for which purpose an ASPI to be created.

  5. Click Save.

An ASPI is created and listed in the list of product identifications.