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TGA presentation about the reclassification of hip, knee and shoulder joints, 3 August 2012

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3 August 2012

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3 August 2012

Presentation: Reclassification of hip, knee and shoulder joints (pdf,208kb)

• Presentation by: Andrea Kunca, Office Head, Office of Device Authorisation, TGA
• Presented at: Seminar for industry, Medina Grand Harbourside, Friday 3 August 2012
• Presentation summary: Reclassification of hip, knee and shoulder joints: outline of the changes, how the two year transition period will work, including implications for fees and charges during the transition period; the process for transition ARTG entries, including information about the new Joint Implant Reclassification application form on eBS: the data sponsors will need to provide to support transitioning device applications; and how applications for new joint replacement implants will be handled.

Text version

The reclassification change

• Implantable hip, knee and shoulder joint replacements are being reclassified from Class IIb to Class III medical devices.
  • Reclassification occurring from 1 July 2012.

Why are these devices being reclassified?

• The changes follow from recommendations made by the Health Technology in Australia review, and subsequent consultation paper; Reforms in the Medical Devices Regulatory Framework, released by the TGA in November 2010.
  • The community is seeking reassurance that the safety, performance and efficacy of hip, knee and shoulder joint implants is adequately demonstrated before implantation.
  • TGA is increasing scrutiny of hip, knee and shoulder joint implants to address community concerns.
  • Aligns Australia's approach to that in place in the EU for these products.

What devices will be affected by the changes?

• Full and partial implantable hip, knee and shoulder joint replacements, intended to replace a natural articulating surface of a hip, knee or shoulder joint.
  • The reclassification will not capture other implantable components or accessories such as:
    • Screws
    • Pins
    • Wedges

Except where the items are part of a joint system.

• Joint systems (those including a number of components) will continue to be classified as per the highest classified component.

What will be different?

• Full and partial implantable hip, knee and shoulder joint replacements will change classification from:
  • Class IIb (medium-high risk medical devices) to;
  • Class III (high risk medical devices).

To better assure the products' safety, quality and performance, regulatory oversight will be increased through:

1. Greater assessment and scrutiny of the joint implant
2. Individual product listings

Application for inclusion on the ARTG

Class IIb	Class III
Documentation
Current manufacturer's evidence	Current manufacturer's evidence for each device
Declaration of conformity	Declaration of Conformity Design examination or type examination certificate for the medical device
Instructions for use (IFU)	Instructions for use (IFU)
Representative labelling for the medical device	Representative labelling for the medical device
Manufacturers brochure & associated advertising material	Manufacturers brochure & associated advertising material that illustrates product variants NJRR data
Fees and Charges
Application fee: $890	Application fee: $1,150 per device no application fee for transitioning devices during 2012-13 (first year of transition period)
Annual charge: $890	Annual charge: $1,150 per device no Class III annual charge for transitioning devices during 2012-13 or 2013-14
Mandatory audit: $6,170 (Level 2)	Mandatory audit: $6,170(Level 2) no mandatory audits for transitioning devices

Evidentiary requirements

Conformity Assessment*

Class IIb	Class III
Application for Conformity Assessment Certificate
$870	$870
Full Quality Management System Audit
$26,000	$26,000
Design Examination
Not applicable	$51,200
Type Examination
Not applicable	$35,700
* Most transitioning devices will not require conformity assessment. Existing EU certification can generally be used.

Post market data

• NJRR data
  • Required for transition from Class IIb to Class III only.
  • A copy of the revision data will need to be attached to the application form for the TGA to assess revision rates.
    • The TGA may select products with high revision rates for non mandatory audit.
• Metal on Metal Joint Implants
  • Applicants wishing to reclassify existing Class IIb ARTG entries will need to declare whether these products include metal on metal articulating surfaces.
  • Will be selected for a Level 2 non mandatory audit.

How to obtain NJRR data?

NJRR revision rates can be obtained by:

Logging into the National Joint Replacement Registry Website, and selecting the implant of interest on the left hand side of the screen.

The revision rate of individual catalogue number ranges can then be obtained by clicking on the box labelled "Click here to display/hide Catalogue Number Ranges:"; selecting the appropriate catalogue number range and clicking on the button labelled "Go" and then clicking on the button labelled "Show". The result should be printed out and provided as evidence with the application.

Timeframes

• Industry will have two years from 1 July 2012 to reclassify full and partial implantable hip, knee and shoulder joint replacements already included on the ARTG.
  • A joint implant reclassification application form must be received by the TGA by 30 June 2014 for each device.
  • If the joint has not been reclassified, sponsors will not be legally able to supply the product in Australia.
  • As Class III entries, one ARTG entry is required for each individual device.
• The TGA will advise sponsors before cancellation of all affected Class IIb full and partial implantable hip, knee and shoulder joint replacement entries remaining on the ARTG as at 30 June 2014.
  • After this date the TGA will cancel affected devices remaining as Class IIb ARTG entries for non-compliance with regulatory requirements.

What information do I need to submit?

• Applications need to be supported with evidence as per other Class III devices:
  • Current manufacturer's evidence
  • Declaration of conformity
    • EC certificate issued by an EU Notified Body or;
    • TGA issued Conformity Assessment Certificate or;
    • MRA certificate
  • Design examination or type examination certificate for the medical device
  • Instructions for use (IFU)
  • Representative labelling for the medical device
  • Manufacturers brochure & associated advertising material that illustrates product variants
  • NJRR data

Many sponsors/manufacturers will already hold this evidence, as it aligns with existing EU requirements for these products

How to submit an application

1. Log on to your eBS portal

2. Click "Create Applications & Submissions"

3. Click "Medical device"

4. Click "Joint Implant Reclassification"

5. Complete the form for a joint implant reclassification

• You will be required to search the ARTG for the Class IIb joint implant you would like to reclassify, then "Clone" this application:

• You will also need to indicate in the "Specific Details" section of the application whether:

1. "Is 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?"
2. The revision rate; expressed in Revisions per Hundred Observed Years reported by the NJRR for the catalogue number range of the implant.

• You will also need to attach "NJRR data" to the application through the function to add supporting documentation:

Other issues

Variants

• 'Variant' is defined in the Therapeutic Goods (Medical Device) Regulations as:

"a medical device, the design of which has been varied, to accommodate different patient anatomical requirements(for example, relating to the shape, size, length, diameter or gauge of the device) or any other variation approved by the Secretary for this definition, if the variation does not change the intended purpose of the device"

• This definition will not be changing as a result of the decision to increase the classification of load bearing joint implants
• A good design examination certificate will have any parameters for the device listed, otherwise a good starting point is the advertising material and other product information
• The product's manufacturer may also be able to provide guidance

Variants (2)

• A list of currently available variants is currently provided in the eBS code tables
• Applications may also be made to the Secretary for approval of additional variants, bearing in mind that these should align with the definition of variant in the Regulations
• There is no fee for applying for a new variant
• New variants must be approved before using them in applications for entry of products onto the ARTG

Currently allowable variants

• "Public TGA information" > "Code Tables" > "Variant Type"

Unique Product Identifier (UPI)

• The concept of a UPI is stated in Regulation 1.6 which states that in relation to the definition of a kind of device under s41BE of the Act,"a characteristic is the unique product identifier given to the device by its manufacturer to identify the device and any variants".
• This definition is not changing as a result of the reclassification of joint implants
• The assigning of UPIs is the responsibility of the manufacturer of a product - often manufacturers are required to nominate a UPI in their declaration of conformity, as part of the conformity assessment process
• All products within a UPI grouping must have the same intended purpose

Unique Product Identifier (UPI) (2)

• Often family names, model names and/or catalogue numbers may be used by manufacturers to form a hierarchy in identifying devices, and a combination of these may be used in assigning UPIs to individual devices
• Different manufacturers identify their product lines in different ways so the TGA does not intend to advise manufacturers specifically on individual acceptable UPIs for their products, so each manufacturer has the flexibility to approach UPIs in a manner which best suits its needs and product suite.
• A number of joint implants are already classified as Class III products on the Register (eg: if they contain material of biological origin) - these may provide examples of how UPIs have been approached for similar products

Unique Product Identifier (UPI) (3)

• UPIs need not follow the same groupings as used on design examination certificates, as overseas notified bodies may use different groupings from those used in the Australian regulatory framework
• UPIs may be assigned independently of GMDN codes
• p177 of the ARGMD provides an example of a possible approach to assigning UPIs

How will the TGA waive Class III annual charges?

Through a dedicated application form for re-classifying products

How will old products used for revision surgery that will not be grandfathered under this initiative be able to be supplied?

Access to these products may be appropriately managed through other means, such as those currently used for unapproved products, such as the Special Access Scheme and Authorised Prescriber Scheme.

Impact of the reclassification on queue time

Reclassification applications will be processed as per our target timeframes of 20-60 working days.

Class IIb entries containing accessory items

All Class IIb ARTG inclusions will be deleted on 30 June 2014 with prior written notice to the sponsor from the TGA.

Maximum eBS file sizes

The maximum combined file size able to be submitted is 100MB.

Resourcing

Communication between the TGA and industry is critical to ensure applications submitted and processed in two year timeframe.

Further information

• TGA website
  Industry > medical devices & IVD's > Regulatory decisions and notices
• eBS
  Latest news
  Joint implant reclassification application form
• Letters to affected or potentially affected sponsors

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