TGA - SME Assist ‘Navigating therapeutic goods regulation‘
SME Assist
5 episodes
9 months ago
Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.
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Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.
TGA - SME Assist ‘Navigating therapeutic goods regulation‘
16 minutes 29 seconds
4 years ago
Supplying certain therapeutic goods for COVID-19
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
TGA - SME Assist ‘Navigating therapeutic goods regulation‘
Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.