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SME guidance material

15 September 2021

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.

Provides an overview of the various steps involved when applying for market authorisation

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.

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

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