Notification form: Reclassification of active medical devices for therapy with a diagnostic function

Closes 25 May 2022

Opened 8 Dec 2020

Overview

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of active medical devices for therapy with a diagnostic function that determines the patient management from Class IIa (low-medium risk)/Class IIb (medium-high risk) to Class III (high risk), effective from 25 November 2021.

From 25 November 2021, active medical devices for therapy with a diagnostic function are required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Requirements for reclassification

The requirements include:

  • More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device;
  • Conformity assessment documents demonstrating procedures appropriate for a Class III device; and
  • Mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

What you need to do

If you are a sponsor/manufacturer/distributor of an active medical device for patient therapy that has a diagnostic function that determines patient management and, your device was included in the ARTG prior to 25 November 2021, or you have submitted an application for inclusion in the ARTG as Class IIa/IIb medical device prior to 25 November 2021 then you need to:

  • Notify the TGA before 25 May 2022 or within 2 months of the start date of your ARTG entry using this form, that you have an inclusion that will need to be reclassified; and
  • Submit an application for your device to be included in the ARTG as a Class III medical device before 1 November 2024.

Transitional arrangements are in place to ensure you can continue to supply your device while you apply for it to be included in the ARTG. To access these arrangements you must submit this form before 25 May 2022. Once you have submitted this form, you will have until 1 November 2024 to submit an application for inclusion in the ARTG. For more information see the guidance document

Note

Applications for ARTG inclusion must be accompanied by appropriate conformity assessment documentation. Please ensure you allow sufficient time to obtain your conformity assessment documentation in order to submit your documents with your application.

About this form:

Please fill in the details of the active medical devices for therapy with a diagnostic function that will require reclassification. You can complete details for multiple ARTG entries in this one form if each ARTG entry has the same manufacturer and sponsor names. Please complete one ‘page’ for each ARTG entry that requires reclassification. Once you have completed a page (ARTG 1), click the 'Continue' button at the bottom of the page. Doing so will return you to the page titled 'Consultation Contents' where you can select another ARTG page (ARTG 2), if necessary, to fill in similar details for another ARTG entry.

Please note: This form is being hosted on a consultation platform, however it is not a consultation and none of the information that you provide using the form will be published.

Audiences

  • Medical Devices & IVDs

Interests

  • Hospitals
  • Regulatory policy
  • Strategic Policy
  • Policy Development