Review of draft guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document ‘Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin – Guidance on the new regulatory requirements and transition arrangements.’

Why your views matter

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024.

Your input is important to ensure the draft guidance outlines the background, key changes, and explains the steps for sponsors and manufacturers to comply with the new requirements.  

Your feedback will inform any changes to the guidance prior to publication on the TGA website. 

If you prefer, you can make a submission directly to the Department via email at the following address:

tgamedicaldevices@health.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please make any proposed amendments using tracked changes. Please also download and complete a copy of the cover sheet. Both are available via links at the bottom of this page.