SURVEY: Software based Medical Devices – further resources for stakeholders
Overview
From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various processes relevant to software as a medical device (SaMD):
- Is my software regulated?
- How the TGA regulates software based medical devices
- Regulatory changes for software based medical devices
- Examples of regulated and unregulated software (excluded) software based medical devices
The Therapeutic Goods Administration (TGA) is conducting an education campaign in order to help stakeholders further understand the new framework and meet the regulatory requirements, in efforts to minimise interruption to the supply of SaMD to Australians.
Why your views matter
What the TGA would like to know:
- The areas of the new framework that you would like more information about; and
- How you would like to receive this information (e.g. factsheets, webinars etc.)
The information gathered from this survey will help us develop material and deliver targeted information about the SaMD framework.
Audiences
- Aboriginal and Torres Strait Islander People
- Academics
- Aged care professionals
- Aged care service providers
- Aged care workforce
- Biologicals
- BPRU staff
- Businesses
- Carers and guardians
- Commonwealth agencies
- Community groups
- Complementary medicines
- Contracted Service Providers
- Families
- General public
- Graduates
- Health professionals
- Health staff
- Health workforce
- HPRG (TGA) Staff
- Medical Devices & IVDs
- Men
- Non-government organisations
- Online and Publications staff
- Other
- Over-the-counter medicines
- Parents
- PCCD
- Prescription medicines
- Secretariat
- Seniors
- State government agencies
- Women
- Young people
Interests
- Children's health
- Health insurance
- Health technology
- Learning and development
- Legislation
- Medicare
- Pharmaceutical benefits
- Regulatory policy
- Rural health services
- Women's health
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