Below are some useful resources. Click the headline or link to download.
Data and case studies about New Zealand HealthTech companies.
- Health and Disability System Review – Executive overview
- Health and Disability System Review – Final report
TGA Software as Medical Device regulation information
The TGA has implemented changes through a number of amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, and the recently finalised Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021 which defines certain types of software that are possibly excluded from regulation.
A draft guidance package has been developed to support these reforms and ensure that the changes are fit for purpose. The guidance includes flowcharts and examples that demonstrate the regulatory changes. The TGA are continuing work on an online classification tool that will be available by 25 February 2021 (check the TGA or ANDHealth websites for further info).
The draft guidance is published on the TGA website at Regulation of software based medical devices:
- 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
An exemption has also been introduced for some clinical decision support software (CDSS) which meet the definition of a medical device. The current documents have been published as drafts and the TGA has invited continued consultation to refine the Guidance as published.
Published online 18 April, 2016, the New Zealand Health Strategy sets the direction of health services to improve the health of people and communities.
The 2016 New Zealand Health Strategy refreshes the previous strategy, developed in 2000. It was developed with the help of sector leaders, independent reports, extensive public consultation, and was informed by other government programmes and initiatives. The Strategy has two parts.
- New Zealand Health Strategy Future Direction Apr16 (5.84mb)
- New Zealand Health Strategy Roadmap Of Actions 2016 Apr16 (1.88mb)
Infographic by AdvaMed on the value of medical technology in controlling & treating diabetes.
Nine Key Considerations By Katrina Destrée
In this article, they cover what HIPAA is, but who should be concerned, what information is impacted, ways HIPAA impacts UX design in medical and life science digital solutions, how to protect your organization against data breaches, cyber threats, and more.
MedTech CoRE Annual Reports
Click the links below to download each annual report.