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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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Government
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All content for TGA - SME Assist ‘Navigating therapeutic goods regulation‘ is the property of SME Assist and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Government
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Supplying certain therapeutic goods for COVID-19
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.