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Reclassification of hip, knee and shoulder implants: Cancellation of Class IIb and transition of Prostheses List entries
This form letter was emailed in January 2014 to individual sponsors identified as having hip, knee and shoulder joint implants with GMDN codes that will be cancelled from the ARTG at 1 July 2014.
Subject: Hip, knee and shoulder joint implants reclassification - cancellation of Class IIb and transition of Prostheses List entries
The purpose of this letter is to inform you of three reclassification issues:
- end of transition period
- cancellation of Class IIb ARTG entries for total or partial hip, knee or shoulder joint implants
- amending Prostheses List entries
End of transition period
After 30 June 2014, sponsors of all Class IIb hip, knee and shoulder joint implants (total and partial) need to have submitted a reclassification application to transition the product to a Class III medical device.
We highly recommend that you submit your reclassification application early to avoid delays with:
- processing your application and including your device as a Class III in the ARTG
- applying for and updating the Prostheses Listing
After 30 June 2014, applications for any hip, knee or shoulder joint implant for ARTG inclusion will be as a Class III medical device and undergo mandatory application audit with associated application fee and annual charge.
Follow this link for detailed information and advice about reclassification and the transition - Reclassification of hip, knee and shoulder joint replacement implants: transition period to 30 June 2014.
Class IIb hip, knee and shoulders cancelled from the ARTG on 1 July 2014
Class IIb hip, knee or shoulder joint implants will be cancelled from the ARTG at 1 July 2014, which means the product (as a Class IIb) cannot be legally supplied in Australia after this date.
Please note, any Class IIb ARTG entries for which there is an outstanding reclassification application at 1 July 2014 will not be cancelled until the reclassification application is finalised.
Affected Class IIb entries have been identified using GMDN codes. It is possible that an inappropriate code may have been used to describe a device that should be subject to the reclassification. It is the responsibility of sponsors to ensure appropriate coding. If you are aware of other Class IIb ARTG entries that should be cancelled please advise the TGA.
Included at the end of this email for your information and review is a list of your organisation's ARTG entries which have been identified for cancellation. You should review this list carefully and advise the TGA if you have any concerns about the cancellation of the entry. For example, please consider whether there are products which you are currently supplying under affected entries which you intend to continue supplying as Class IIb after 1 July 2014. It may be appropriate to continue the ARTG entry, vary the entry, or a new ARTG entry may be required to cover these products.
You can email questions or details of other Class IIb devices that should be cancelled to email@example.com or phone 1800 141 144 (freecall within Australia).
Amending Prostheses List entries [if applicable]
Some sponsors choose to have their devices listed on the private health insurance Prostheses List in order for the devices to be reimbursed by private health insurers.
As ARTG numbers are changed during reclassification, reclassified devices (Class IIb to Class III) currently listed on the Prostheses List will require their listings to be to be updated in order to remain on the Prostheses List.
Failure to update the listing for a reclassified device with a new ARTG number may result in the device being removed from the Prostheses List.
To assist you in this process [if applicable] we have prepared a spreadsheet of your approved reclassification applications (Attachment A).
- You need to complete the following columns in the spreadsheet of approved reclassification applications:
- Current billing code
- Catalogue number/s
- Component name, sizes and description as detailed on the Prostheses List
- You also need to check the other columns of the spreadsheet list for correctness. If the information in this list is not correct you will not be able to transition your reclassified ARTG entry and your device may be removed from the Prostheses List.
- You need to complete your company's contact information and sponsor's declaration (Attachment B) and email this and the spreadsheet to firstname.lastname@example.org.
If you have queries about amending your listings, please contact the Prostheses Hotline on 02 6289 9463 or email email@example.com.
Office of Devices Authorisation
28 January 2014
[Attachments were provided to individual sponsors with their applicable PLAC and ARTG entries]