You are here
SME guidance material
SME Assist provides a range of guidance material to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations.
- Overview of applying for market authorisation
Provides an overview of the various steps involved when applying for market authorisation
- Researcher considerations
Assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation.
- Overview of medical devices and IVD regulation
Introduces you to some of the concepts and terminology used in medical device regulation.
- Understanding ingredient requirements
Helps you understand and interpret the relevant legislative instruments for ingredients.