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TGA’s Reclassification of Medical devices around the corner. Ready?

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The New Reclassification system for medical devices is round the corner to its effective date (25 Nov 2021) of implementation. The clock is ticking on Australian reclassification submissions. The Reclassification process is based on the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 and was originally scheduled to take effect on August 25, 2020. The TGA announced a delay to implementation of this step as a result of difficulties relating to the COVID-19 pandemic.

  1. Active medical devices for therapy with a diagnostic function – Class III
  2. Medical devices that administer medicines or biologicals by inhalation – Class IIa or Class IIb, as applicable
  3. Active implantable medical devices (AIMDs) – Class III
Timelines
New classification rules will apply to all new applications for ARTG inclusion from-November 25,2021
All Manufacturers or Sponsors must submit an online form to notify the TGA that the device will need to be reclassified before-May 25, 2022
Must subsequently file an application for your device to be included in the ARTG for the new classification beforeNovember 1, 2024

1.Active medical devices for therapy with a diagnostic function

2. Medical devices that administer medicines or biological by inhalation – Class IIa or Class IIb, as applicable

The amendments include the reclassification of medical devices that administer medicines or biologicals by inhalation, effective from 25 November 2021.

Requirements for reclassification include:

3Active implantable medical devices (AIMDs) – Class III

Additionally, for AIMDs listed on the Prostheses List, an application to amend the Prostheses List billing code will be needed once the new ARTG listing number is issued, to avoid delays and inaccuracies in benefits paid by private health insurers. Please be noted that the latest version of Prostheses List is effective from July 1st, 2021. Prostheses include surgically implanted prostheses, human tissue items and other medical devices.