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 device and IVD regulation

Introduces you to some of the concepts and terminology used in medical device regulation.

• Ingredients basics

Helps you understand and interpret the relevant legislative instruments for ingredients.