This guidance is to assist sponsors of Class IIb hip, knee and shoulder implants (total and partial) to complete the application for reclassification to class III medical devices by the end of June 2015.

Reviewing the GMDN codes for reclassification

It is imperative that both the GMDN code and the unique product identifier are consistent and accurately describe the hip, knee and shoulder joints that are reclassified as Class III medical devices.

If the GMDN code that you used previously to include a Class IIb joint implant on the ARTG is now obsolete and has been replaced with more appropriate terms:

• obtain the updated GMDN code from your manufacturer
• ensure the manufacturer’s updated declaration of conformity states the new GMDN code
• submit the updated manufacturer’s declaration of conformity with your application for reclassification.

Guidance on GMDN codes

• Australian regulatory guidelines for medical devices - Section 10, pages 172-174

Unique product identifiers for reclassification

Applications to reclassify joint replacement implants from Class IIb to Class III are for a single kind of medical device so that the device and any of its variants can be individually identified in the ARTG.

For Class III medical devices, under Regulation 1.6 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), the Unique Product Identifier (UPI) is the additional characteristic that determines a kind of medical device.

This means:

• Variations of the same kind of device (e.g. a variation in size) would be covered by the one application and result in one ARTG entry.
• Devices that have been changed so that they no longer fit the description that identifies that unique device (i.e. no longer the same unique product identifier) need a separate application and ARTG entry. For example:
  • A femoral head component composed of aluminium oxide is a different device requiring a separate application and ARTG entry to a femoral head component composed of zirconia-alumina.

Supporting information from the manufacturer such as the design examination certificate and product information may help distinguish whether the transitioning joint replacement implant is a different kind of medical device. This information may include details on the composition of the materials and information on variants (e.g. size, shape).

Related guidance on unique product identifiers

• Australian regulatory guidelines for medical devices - Section 10, page 171

Variants for reclassification

The list of 'allowable variants' has been updated to include new variant codes which will specifically facilitate the reclassification of hip, knee and shoulder joint replacement implants from Class IIb to Class III medical devices.

The new codes have been added on the basis that the variants allow for different patient anatomical requirements. They do not change the intended use of the implantable joint.

Two additional variant codes - size (nonspecific range) and height (non-specific range) - have subsequently been added. The additions since 15 November 2012 are:

• thickness
• angle
• offset
• taper
• number of holes
• size
• height.

Composition of materials

Stabilisation, material and surface finishes are not allowable variants.

The primary implants are different medical devices to the revision implants. The 'shape' variant cannot be used as a means of grouping both the primary and revision implants together. The need separate reclassification application.

How to access the list of variants in TGA eBusiness Services

To access the list of allowable variants for class III medical devices (including class III hip, knee and shoulder joint implants:

• Go to the TGA eBusiness Services website
• Click on Public TGA Information from the drop down menu on the left hand side, from the main page
• Click on Code Tables
• click on Variant type

Guidance on variants

• Australian regulatory guidelines for medical devices - Section 10, pages 175-178

Tips when completing the reclassification application form in TGA eBusiness Services

When completing the application for reclassification in TGA eBusiness Services;

• be sure to view the whole 'variant code type' list in eBusiness to find the relevant variant type as there are 2 pages to this list
• The range field is mandatory - when using a non-specific code describe the 'range' as per the product literature, e.g. 'size' may be described in terms such as '1 - 9' or 'A - F', rather than as 'cm' or 'mm'.