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
- Seniors
- Men
- Women
- Carers and guardians
- Families
- Parents
- Young people
- Academics
- Non-government organisations
- State government agencies
- Commonwealth agencies
- Local governments
- Health professionals
- Health workforce
- General public
- Community groups
- Businesses
- Contracted Service Providers
- Aged care service providers
- Aged care workforce
- Aged care professionals
- BPRU staff
- Graduates
- Online and Publications staff
- Secretariat
- PCCD
- Health staff
- HPRG (TGA) Staff
- Prescription medicines
- Complementary medicines
- Over-the-counter medicines
- Medical Devices & IVDs
- Biologicals
- Other
Interests
- Health technology
- Medicare
- Legislation
- Pharmaceutical benefits
- Health insurance
- Rural health services
- Regulatory policy
- Women's health
- Children's health
- Learning and development
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