Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

Closes 30 Jun 2029

Opened 1 Jul 2023

Contact

1800 141 144

devices@tga.gov.au

Overview

From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification.

Background

In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019, certain categories of medical devices are required to be reclassified so they align, wherever possible with the changes introduced in European Union (EU) medical devices framework.

Transitional arrangements are in place to ensure sponsors of the affected Australian Register of Therapeutic Goods (ARTG) entries can continue to supply their devices while they apply for inclusion in the ARTG at the new classification, in accordance with Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.

Some of the transitioning devices are also in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (the List; previously known as the Prostheses List) and require their new ARTG entries to be included in the List. As the List is only updated few times a year there may be delays in including the new ARTG entries. This may result in a sponsor having to maintain two ARTG entries for the same product at different classifications.

Therefore, a waiver or refund of the annual charge of the ‘old’ ARTG entry, for transitional medical devices, has been introduced to ensure continuity of inclusion in the List and reduced financial burden for sponsors.

Eligibility for annual charge waiver or refund

To be eligible for annual charge waiver or refund at any time during charge year:

  • The medical device must be a transitional medical device,
  • The device must be included in the ARTG under two different classifications as mentioned in Column 1 and Column 2 in the table below,
  • The transitional ARTG entry must not include any non-transitioning medical device, and
  • The same kind of medical device is also included in the List, as in force from time to time.

Transitional medical device
 

Column 1

Column 2

Item

Kind of medical device

Class of medical device or application

1

a medical device of a kind described in subclause 3.4(4B) of Schedule 2

Class IIb

2

a medical device of a kind described in clause 5.10 of Schedule 2

Class I or Class IIa

3

a medical device of a kind described in clause 5.11 of Schedule 2

Class I, Class IIa or Class IIb

4

a medical device of a kind described in subclause 4.2(4) of Schedule 2

Class IIa or Class IIb

5

a medical device of a kind described in subclause 3.2(3A) of Schedule 2

Class IIa or Class IIb

6

a medical device of a kind described in subclause 5.7(1) of Schedule 2

 Class AIMD

Please note – If you have submitted a declaration for exemption from annual charges under the Annual Charge Exemption (ACE) scheme or an application for waiver under Regulation 43AAH of the Therapeutic Goods Regulations 1990, you may are not eligible for annual charge waiver or refund under the mentioned above regulatory amendments.

Transitional medical device eligible for waiver or refund

Please complete and submit this form if your ARTG entry is eligible for an annual charge waiver or refund. Using this form, you can provide information on up to 10 eligible ARTG entries, if each ARTG entry has the same manufacturer, sponsor, and the waiver or refund request is for the same financial year.

About this form

Please complete one page (i.e. Transitioning ARTG Entry – 1) for each eligible ARTG entry as the fields on each page collects information related to one transitioning ARTG entry and corresponding new ARTG entry. Once completed, click ‘Continue’ to return to the landing page titled ‘Contents’. From here, you can select another page for listing the details related to an additional transitioning ARTG entry. One form can be used for up to 10 eligible ARTG entries, if you are seeking waiver or refund for more than 10 ARTG entries, please submit multiple forms or contact the TGA at devices@tga.gov.au to discuss.

For the question regarding SAP invoice number (question 4 on ‘Transitioning ARTG Entry' page):

  • If you are requesting annual charge waiver/refund for a transitioning AIMD (Active Implantable Medical Device) ARTG entry, please provide the SAP invoice number for the Class III ARTG entry.
  • For the remaining reclassification reforms (as mentioned in the table above), please provide the SAP invoice for the transitioning ARTG entry with the old classification.

Please note: This form is being hosted on a consultation platform; however, it is not a consultation and information provided in the form will not be published. 

This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA.

Provide information on eligible medical device(s)

Online Form

Audiences

  • Non-government organisations
  • Businesses
  • Industry
  • Sponsors
  • Manufacturers
  • Medical Devices & IVDs

Interests

  • Legislation
  • Administration
  • Applications and Forms