September 6, 2022
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance requirements and guidelines for active medical devices.
UDI implementation updates
First, the TGA has published a new consultation paper seeking stakeholder feedback on the regulator’s proposed UDI framework. TGA proposals include:
- Accepting device labels already compliant with US as well as European Union requirements;
- Phased UDI implementation approaches according to device risk classifications;
- Regulatory scope and exemptions;
- Data provisions and maintenance;
- Labeling and documentation requirements;
- Adoption and application in healthcare system settings
The TGA is accepting comments until October 11, 2022.
Guidance on TGA Essential Principles compliance
Second, Australian regulators have issued new guidance on Essential Principles, which are legislative requirements regarding medical device and in vitro diagnostic (IVD) safety and performance. Although online content related to Essential Principles remains under development, the TGA has published information on the following:
- Principle 1 on medical device use that does not compromise health and safety;
- Principle 2 on conformance of device design and construction to safety principles;
- Principle 9 on device construction and environmental properties;
- Guidance on demonstrating compliance with Essential Principles
Guidance on active medical device requirements
Third, the TGA has updated its guidance on regulatory requirements for active medical devices. The updated guidance covers definitions and requirements regarding active devices, as well as identifies which Essential Principles and electromedical safety requirements apply to these products.
Specific requirements are also included for active devices such as:
- Devices with telecommunication features or radio transmitters;
- Radioactive medical devices
- Radiating medical devices
- Programmable and programmed devices, including software