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.