In this episode, we talk with Brian Chamberlain from the Medical Devices Authorisation Branch at TGA and explore:

• some of the products being supplied for COVID-19


• how these are regulated


• where to start if considering supplying these products in Australia


• how the features of a product can impact how it’s regulated


• tools and information helpful for those new to supplying therapeutic goods


• the application process

This podcast series is presented by the SME Assist team at TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.

You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly.

Phone:            1800 020 653

Email:              sme.assist@tga.gov.au

Social Media: https://www.tga.gov.au/social-media

TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics

Links and useful information

• TGA website tga.gov.au


• The ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg


• Disinfectants, sterilants and sanitary products https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products


• COVID-19 landing page https://www.tga.gov.au/collection/covid-19


• Australian regulatory guidelines for medical devices (ARGMD) https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd


• Australian regulatory guidelines for OTC medicines (ARGOM) https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom-0


• Is my product a therapeutic good? https://www.tga.gov.au/sme-assist/my-product-therapeutic-good


• Is my product a medical device? https://www.tga.gov.au/my-product-medical-device


• What classification is my medical device? https://www.tga.gov.au/sme-assist/what-classification-my-medical-device

Host: Steven Smith-Fleury

Guest: Brian Chamberlain