Therapeutic goods regulation and legislation can be challenging to navigate. The SME Assist hub is designed to help small and medium enterprises, and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.
Choose the statement below that best matches your experience.
Articles to help you understand what your therapeutic good is, what your obligations are, how the TGA regulates and where you can go for 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 tools designed to help businesses who are new to therapeutic goods regulation.
- Is my product a therapeutic good?
- What classification is my device?
- Which clinical trial scheme should I choose?
Subscribe to the SME Assist email list to stay up to date with latest SME information from the TGA.
Discover training opportunities for small and medium enterprise, offered by TGA and external organisations.
- The role of the TGA
- A summary of supplying therapeutic goods in Australia
- Benefits vs risks approach to regulating therapeutic goods
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