Product Identifications

The Product Identifications tab lists the authority-specific product identifications (ASPI), which are created for the medical device product across all the countries and regions.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader,

To access this page from the Device Identification Home page:

To access this page from the Products page:

  • Open the required product. For more information, see Opening a Product.
  • In the navigation pane, click Additional Details.
  • From the page, click Product Identifications tab.

From the page toolbar, use the filter to list the product identifications according to the status:

  • Active: Lists the product identifications that are active.
  • Released: Lists the product identifications that are released.
  • All: Lists all the product identifications.

This topic describes:

This page discusses:

Columns

Column Name Description
Name The name of the ASPI.
Revision The revision number of the ASPI.
State The current lifecycle ot the object.
Region The region, which is selected for the ASPI.
Country The country, which is selected for the ASPI.
Class The risk category, which is displayed as class for the ASPI.
Market Authorization The associated MAC for ASPI and empty for DI
Note: This column is displayed if you view the lists of ASPIs from the home page.
Device Identification The device identification (DI) that is connected with the country or region in which the ASPI is created.
Notes:
  • If the DI is not connected with the country or region, the values are displayed as Yes and No.
  • The DI column is not displayed for the revision of an ASPI.
Authorized Representative The authorized representative that is connected with the ASPI.
Device Exempt from Premarket Submission or Conformity Assessment Whether the ASPI is exempted from the premarket submission or conformity assessment.
Owner The person who is responsible for the ASPI.
Medical Purpose The medical purpose for which the ASPI is created.

Actions and Toolbar Commands

Action Description For More Information
Edit Lets you edit the details of the selected ASPI. You can edit the details before promoting the ASPI to the Review state. Editing the Product Identification Details
> Submit to Review Lets you promote the selected ASPI to the Review state.
Note: This action is displayed if you view the lists of ASPIs from the home page.
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> Approved Lets you promote the selected ASPI to the Approved state.
Note: This action is displayed if you view the lists of ASPIs from the home page.
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> Submit to Released Lets you promote the selected ASPI to the Released state.
Note: This action is displayed if you view the lists of ASPIs from the home page.
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> Generate GTIN Generates a submission file for the selected ASPI object and submits it to the regulatory authority. You can generate the GTIN only for the ASPI that is created for the EU region. Submitting Device Identification to Regulatory Authority Through AS2 Gateway
> Adds Existing Adds the existing ASPI to the context product. You can add the ASPI that is not connected with the context product. -
> Revise Creates a revision for the ASPI. The revised ASPI has the same ASPI number with the added to the previous ASPI. The first revised ASPI is with revision one and on revising it, a new ASPI is created with revision two and so on. You can revise the ASPIs that are in the Released state.

Only a Product Manager can revise an ASPI. Only some attributes of an ASPI can be changed during the revision.

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> Remove Removes the selected ASPIs from the context product.
Note: You cannot remove the ASPI if the earlier revision is present for the selected ASPI. Also you cannot remove the selected ASPI that is connected with the DI and the status of the context DI is above Approved.
> Delete Deletes the selected ASPI from the context product. You can delete the ASPI before promoting to the Review state.
Note: You cannot delete the ASPI if the earlier revision is present for the selected ASPI. Also you cannot delete the selected ASPI that is connected with the DI and the status of the context DI is above Approved.
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Insert new row Lets you insert the rows above or below of the selected row.
Note: This option is enabled in the Edit mode. When you enter the row, add the details in the related columns and the ASPI is created with the added details.
 Creating a Product Identification
Remove inserted row(s) Lets you remove the inserted rows. -