IMPORTANT TGA UPDATES

Please note the following updates from the TGA should your organisation be required to take any action or wish to be involved in consultation processes

Please see here for the TGA’s 4 July Industry Update Bulletin - main point of interest is a click-through for more information on the need to comply with regulatory requirements for exempt medical devices.

Please see here for the TGA RegTech Weekly Update dated 5 July – which covers new TGA phone numbers, the ARTG Data Integrity Project, the Proposed MDSAP pathway for Class III Medical Devices and the current AI consultation around clarifying and strengthening regulations. Also, this update includes links to New Guidance on Excluded Software, Updated Guidance on Regulatory changes for software-based medical devices, new webpages for the Classification of Medical Devices and updates to webpages for What classification is my medical device?

Please see here for details on an International Medical Device Regulators Forum that is conducting a public consultation on Good machine learning practice for medical device development and has an open consultation on guiding principles should you want to have your say. The consultation closes on 30 August 2024.

Please see here for details on public consultation for proposed reforms to Part 5 of the Therapeutic Goods Regulations as the TGA seeks to strengthen and modernise the legislative framework for the examination, testing and analysis of therapeutic goods. They state they will seek to strike the right balance between consumer safety and without imposing unnecessary burdens on industry, and ODMA recommends that organisations engage, given that these legislative changes can impact your business, and we need to ensure reforms are fit for purpose. This consultation closes 18 August 2024.