The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device reforms due to COVID-19. So, the medical device industry has more time to adapt to the reforms. We have compiled some of the more significant Australian medical device reforms below.
Significant amendments regarding software-based medical devices (including SaMD):
- The classification rules are “largely aligned with the software rules in the EU MDR 2017.” Thus, classification is based on the potential of the SaMD to cause harm through the provision of incorrect information.
- A device may be a lower classification if a healthcare professional is involved
- Devices intended to provide therapy via the provision of information (e.g., a medical device intended to provide cognitive behavioural therapy) will potentially be a higher class in some cases.
- Clarifications around Essential Principle 12.1 (expectations regarding cybersecurity, data management, etc.)
- Addition of Essential Principle 13B (requiring identification of the current version and build number to be made accessible by, and identifiable to, users of medical devices that are, or that incorporate, software)
These reforms will be implemented February 25, 2021. As for the Essential Principles amendments, their implementation has been delayed for up to two years after the commencement of European Union Medical Device Regulation changes and IVD Medical Device Regulations (likely to be May 2022).
Significant device reclassifications:
The device reforms have also brought about some up-classification. The list below is general; some exceptions remain to the new classifications.
- Spinal implantable medical devices are moving from Class IIb to Class III
- Active medical devices for therapy with diagnostic function are moving from Class IIa/b to Class III
- Active implantable medical devices are moving from Class AIMD to Class III
- Medical devices that administer medicines or biologicals by inhalation are moving from Class I or IIa to Class IIa or IIb
- Medical devices composed of substances that are introduced into the body through a body orifice or applied to the skin are moving from Class I or IIa to Class IIa, IIb, or III
- Medical devices used in direct contact with the heart, central circulatory or central nervous systems are moving from Class IIa to Class III
These reforms will be implemented November 25, 2021.
See our other posts on TGA here: https://www.softwarecpr.com/tag/tga/