{"id":4520,"date":"2021-06-24T10:21:00","date_gmt":"2021-06-24T10:21:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4520"},"modified":"2024-07-01T06:15:18","modified_gmt":"2024-07-01T06:15:18","slug":"tgas-reclassification-of-medical-devices-around-the-corner-ready","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/tgas-reclassification-of-medical-devices-around-the-corner-ready\/","title":{"rendered":"TGA’s Reclassification of Medical devices around the corner. Ready?"},"content":{"rendered":"\n

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<\/a> and was originally scheduled to take effect on August 25, 2020. The TGA announced<\/a> a delay<\/a> to implementation of this step as a result of difficulties relating to the COVID-19 pandemic.<\/p>\n\n\n\n

In order for sponsors to continue to supply, government has informed all the stakeholders prior via an email, specifying new policies for the inclusion of non-sterile, non-measuring Class 1 Medical Devices.<\/p>\n\n\n\n

The newly published guidance documents cover three of the six categories subject to reclassification. All are being up-classified to reflect reevaluation of their risk levels, with the exception of active implantable medical devices (AIMDs), which are being eliminated as a separate device class and merged with Class III medical devices.<\/p>\n\n\n\n

The Guidance Documents address the following categories, with their new classifications provided alongside:                       <\/p>\n\n\n\n

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

    1.Active medical devices for therapy with a diagnostic function<\/a><\/strong><\/p>\n\n\n\n

    From 25th<\/sup> November 2021 active medical Devices for therapy with diagnostic functions will be required to meet regulatory requirements demonstrating the safety and performance for Class III Medical devices.<\/p>\n\n\n\n

    Requirements for reclassification include:<\/strong><\/p>\n\n\n\n