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Therapeutic goods regulation and legislation can be challenging to navigate.
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.
Choose the statement below that best matches your experience.
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Subscribe to the SME Assist email list to stay up to date with the latest SME information from TGA, including upcoming workshops and events.
Guidance articles to help you understand the basics of regulation, how TGA regulates therapeutic goods, what your obligations are, and where you can go for more help.
- Basics of therapeutic goods regulation
- Overview of applying for market authorisation
- Medical devices regulation: an introduction
- When to engage with the TGA
- Useful resources for business
Interactive decision tools
Interactive decision tools ask you a series of questions about your product to help you understand your next steps.
- Is my product a therapeutic good?
- What classification is my device?
- Which clinical trial scheme should I choose?
- What type of GMP application do I require?
Workshops and events
SME Assist workshops and events where TGA specialists can help you to understand therapeutic goods regulation and your legislative responsibilities.
The links below will take you directly to materials intended for a more advanced audience. These include forms, targeted guidance and the TGA's eBS portal.
Standards, guidelines and publications:
- Prescription medicines
- Over-the-counter medicines
- Complementary medicines
- Medical devices & IVDs
Phone: 1800 020 653