TGA Updates Rules for Medical Device Manufacturers

On June 14th, 2024, the Therapeutic Goods Administration (TGA) made some amendments (2024 Measures No.2) to Australia’s medical device regulations. The regulatory landscape for medical devices in Australia is evolving with several significant changes set to take effect, impacting manufacturers and sponsors. Here’s a concise breakdown of the updates affecting the medical device sector:

1. Transition Period for SaMD

Manufacturers affected by the re-classification of software devices can now apply for TGA Conformity Assessment (CA) before November 1, 2024, instead of needing an ARTG application. This allows them to qualify for a transition period under new regulations.

2. Changes in Mandatory Application Auditing

Starting July 1, 2024, the list of devices requiring mandatory application audits for ARTG inclusion will be simplified. This includes only Class III medical devices and a specific group of IVD devices, excluding others such as device disinfectants and contraceptives.

3. Expanded Supporting Evidence

Effective July 1, 2024, the list of supporting evidence allowing applications to bypass mandatory audits will expand. This includes certifications like EU MDR/IVDR, which was previously included, Health Canada medical device licenses, US FDA PMA, Japan’s MHLW/PMDA approvals, and entry in Singapore’s HSA Register.

4. Notification Requirements for IVDs

Sponsors of In Vitro Diagnostic (IVD) devices must notify TGA with product names or intended purposes, aligning with Regulation 5.3. Starting July 1, 2024, at least 20 workdays’ notice is required before import or supply if these details are not already in the ARTG entry.

Manufacturers and sponsors should prepare to comply with the updated requirements to navigate these regulatory shifts effectively and maintain market access. Should you have any questions or concerns regarding these regulatory shifts, don’t hesitate to contact Asia Actual Australia.