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Information to include in your application for reclassification

4 July 2014

This guidance is to assist sponsors applying for reclassification and assessment of their class IIb ARTG entries for hip, knee and should joint implants (total and Partial) to class III medical devices.

The guidance outlines the information you need to include in your application for reclassification of your Class IIb hip, knee or shoulder joint implant.

Information needed in your application for reclassification

You will need to include the following information in your application:

Post market data from the National Joint Replacement Registry (NJRR)

Your application to reclassify class IIb hip, knee and shoulder joint implants (partial and total) needs to address the revision rate (expressed in Revisions per Hundred Observed Years) as reported by the National Joint Replacement Registry for the catalogue number range of the implant(s) subject to this application for reclassification.

This information will be assessed instead of assessing clinical data which would normally occur if the application was for a new implant, not previously supplied to the Australian market.

How to obtain information from the National Joint replacement Registry

To obtain the revision rate:

  • Use your log-on access to the National Joint Replacement Registry. If your organisation does not have log-on access to the NJRR:
    • contact the Australian Orthopaedic Association's NJRR Coordinator, Ann Tomkins:
  • log into the National Joint Replacement Registry website
  • select the implant of interest by double clicking on the relevant icons on the 'Tree View' on the left hand side of the Search Window
  • double click to select a specific implant to refresh and display the revision information on the right side of the search window

This will display the revision information for all catalogue number ranges over the entire period of data collection.

To obtain the revision rate of individual catalogue number ranges:

  • single left click on the line item in the box containing the list of catalogue number ranges at the top right hand side of the search screen

You can select several catalogue number ranges simultaneously.

When selected, a catalogue number range is highlighted and the text changes to italics.

To unselect the range:

  • Left click a catalogue number range that has already been selected

Once the appropriate catalogue number ranges have been selected:

  • click on the button labelled '^ Filter' to display the revision information for the selected items only
  • print or scan the web page(s); or transcribe the details transcribed into a Word document or Excel spreadsheet
  • attach the revision rate information to your application.

What to do if there is no information in the National Joint Replacement Registry

If there is no information in the National Joint Replacement Registry for the implant:

  • Attach a document noting that the data is unavailable and any relevant rationale.

This may occur if, for example, the implant is:

  • relatively new to the Australian market
  • used only for revision surgery (data on these devices is collected by the NJRR but generally not included in basic reports available through the website).

Manufacturer's conformity assessment evidence

When applying for reclassification, you will need to submit the following documents:

  • conformity assessment certification for the conformity assessment procedure that has been applied by the manufacturer
  • the design examination certification
  • the manufacturer's Australian declaration of conformity

Note: You can submit a summary technical report in lieu of the Design examination certification during the transition period for partial joint implants if:

  • the implant is not classified as a Class III medical device in Europe
  • the manufacturer does not have a design examination certificate issued by a European notified body

Guidance on conformity assessment evidence

Instructions for use and representative label

Include in your application, a copy of the manufacturer's instructions and representative label for use for the joint implants you are applying to reclassify.

These instructions for use will be assessed to ensure they comply with Essential Principle 13.4 of the Therapeutic Goods (Medical Device) Regulation 2002.

Guidance on essential principles for labels and instructions for use

Manufacturer's brochure and associated advertising material

Include the manufacturer's brochure as well as any advertising material that will support the device when supplied in Australia.

For advertising material presented in electronic format:

  • provide a direct link to the relevant area of your website to assist us to identify and review the material related to the device you will be supplying in Australia.

Note: It is a condition of inclusion under Section 41FN (5) that any advertising material relating to medical devices is consistent with the intended purpose as certified in the device application.