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Applying for reclassification

4 July 2014

When to apply for reclassification

You are encouraged to submit applications to reclassify your Class IIb implants now to ensure:

  • adequate time to resolve any issues before the end of the transition period
  • minimise delay due to a possible glut of applications at the closing period
  • adequate time to take care of ancillary issues such as registration on PLAC

How to apply for reclassification

To apply for reclassification of your Class IIb hip, knee or shoulder joint implants (total and partial):

  • log into TGA eBusiness Services using your access and password
  • complete the 'Joint Implant Reclassification form'
  • attach the following information to the reclassification application form:
    • post market data from the National Joint Replacement Registry (NJRR)
    • manufacturer's conformity assessment evidence
    • instructions for use and representative label
    • manufacturer's brochure and associated advertising material
  • answer YES or NO - to the question in the applicant form:
    • The implant an acetabular component, acetabular component liner, or femoral component that has been specifically designed to be used (or can only to be used) in hip replacements with a metal on metal articulation?
  • submit to the TGA.

The TGA will:

  • Waive some fees and charges associated with the transition
  • Consider the application as a reclassification (see "Fees or charges associated with reclassification?" below for details)
  • Assess the information to validate:
    • the Unique Product Identifier (UPI), associated variants
    • the intended purpose and functional description of the device that has been indicated in the application
    • the appropriate conformity assessment procedures have been applied.

Guidance to assist you to complete your application

Fees or charges associated with reclassification

The following fees and charges have been waived to support you reclassifying existing ARTG inclusions:

  • The mandatory application audit fees during the three year transition period
  • The Class III annual charges until 30 June 2015 for those implants requiring reclassification.

Also:

  • Class IIb annual charges will continue to be applied while there is a Class IIb entry on the ARTG to prevent two annual charges for the same device within the same year.

What happens at the end of the transition period?

If an application for reclassification has been submitted and is still in progress on 1 July 2015, the implant can be supplied under the existing Class IIb entry until we make a decision.

What happens if I do not apply for reclassification by the end of the transition period?

If you do not apply for reclassification by the end of the transition period, we will advise you of the intention to cancel your ARTG entries for any Class IIb total or partial hip, knee or shoulder joint implants that remain as at 30 June 2015.

If your class IIb ARTG entry is cancelled (and you do not have an ARTG entry for the implants as Class III medical devices), you will not be legally able to supply the implants in Australia until you have an ARTG inclusion for the class III implant.

Withdrawing an application

To withdraw an application notify the TGA in writing by emailing devices@tga.gov.au.