“The TGA has been very active with guidance recently. It is important to stay current to maintain compliance and access to the market here.”

Jack Liang

Managing Partner, Asia Actual Australia

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TGA Updates Rules for Medical Device Manufacturers

Published on: June 25th, 2024

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.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in Australia. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services in Australia and the rest of Asia.

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