Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

Closes 30 Jun 2029

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Transitioning ARTG Entry - 8

This page has questions about the eighth ARTG entry that is transitioning and may be eligible for an annual charge waiver or refund. Enter the eighth transitioning ARTG entry in the relevant field and provide further RELATED information in subsequent fields.

1. Transitioning ARTG entry number - 8
2. Are there any non- transitioning devices currently included under the ARTG entry?
3. Is the transitioning ARTG entry listed on the Private Health Insurance list (previously known as Prostheses List)?
4. Provide the SAP invoice number for the annual charge related to the ARTG entry that you are applying to be waived or refunded.

If you are requesting an annual charge waiver or refund for a transitioning AIMD ARTG entry, please provide the SAP invoice number for the Class III ARTG entry. For all other devices that are required to be reclassified please provide the SAP invoice number for the transitioning ARTG entry.

5. For the SAP invoice provided above, have you submitted a declaration for exemption from annual charges under the ACE or an application for waiver under Regulation 43AAH of the Therapeutic Goods Regulations 1990?
6. What is/are the ARTG entry(ies) at the new classification in accordance with the classification rules tabled below?
 

Column 1

Column 2

Item

Kind of medical device as per Therapeutic Goods (Medical Devices) Regulations 2002 

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
7. Have you submitted an application to include the new ARTG entry(ies) on the Private Health Insurance list (previously known as Prostheses List)?
8. Provide as much of the following information as possible related to inclusion of the new ARTG entry(ies) in the Private Health Insurance list (previously known as Prostheses List).

If your application(s) to include the new ARTG entry(ies) in the Private Health Insurance list (previously known as Prostheses List) is/are not yet approved, please type ‘The application(s) is/are ongoing’ in the field above.

9. Provide additional information that may be useful for the TGA while considering the 'Transitioning ARTG entry – 8' for annual charge waiver or refund.