Notification form: Reclassification of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)

Closes 25 May 2022

Opened 8 Dec 2021

Overview

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of all surgically invasive medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or central nervous system (CNS) from Class IIa (low-medium risk) to Class III (high risk), effective from 25 November 2021.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices, regardless of the duration of action of the device (transient, short-term or long-term).

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 a medical device that is used in direct contact with the heart, CCS or CNS and, your device was included in the ARTG prior to 25 November 2021, or you have submitted an application for inclusion in the ARTG 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 under the correct classification 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 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) 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