This article discusses about the TGA Regulation the transitional steps that sponsors of medical devices intended to be used in direct contact with the heart and central circulatory system must do in order to be in compliance with new laws and regulatory criteria starting on November 25, 2021. The TGA Regulation specifications include:

  • A more thorough evaluation of the manufacturer’s quality management systems and evaluation of the technical documentation for each device.
  • Conformity assessment documents confirming Class III device-specific processes.
  • The TGA required a review of devices including applications, including an assessment of clinical evidence..

Medical equipment in close proximity to the Heart and CCS, or CNS

  • Medical devices in direct contact with the heart, CCS or CNS will be reclassified to Class III regardless of duration of action.
  • The classification of medical devices used in direct contact with the heart, CCS, and those intended for temporary use will change from Class IIa to Class III.
  • Medical devices that come into direct contact with the heart, CCS, or Brain and are intended for long-term use fall under the same classification of Class III.

What should manufacturers do?

Transitional arrangements are in place to ensure that medical devices can continue to be included in the ARTG while they are reclassified.

  • If manufacturers  have an inclusion that needs to be classed, notify the TGA by May 25, 2022.
  • Before November 1st, 2024, manufacturers must submit an application for equipment to be classified as a Class III medical device in the ARTG.
  • Manufacturers must notify the TGA that they have an inclusion that will need to be reclassified Within 2 months of the start date of your ARTG entry 
  • Before November 1, 2024, manufacturers must submit an application for their devices to be classified as a Class III device in the ARTG.
  • If manufacturers do not notify the TGA of their intention to apply for the ARTG as a Class III device, they will no longer be eligible for transitional arrangement. Cancel ARTG inclusion from 25 May 2022, 
  • Manufacturers must notify the TGA of their device before 1 November 2024 to be eligible for Class III inclusion, Cancel ARTG inclusion from 1 November 2024.

Contact our Morulaa advisors for assistance with regulatory compliance in India and Southeast Asia, or subscribe to our website to get the most recent medical news from across the globe.

Source :  Department of Health, Australian Government


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