Summary of the TGA’s Guidance Document for Active Medical Devices
The TGA’s August 2023 guidance focuses on requirements for active medical devices, which are defined as devices that significantly convert energy to operate. This excludes devices operated by gravity or human effort. The guidance clarifies classification rules, essential principles, and different types of energy like chemical and elastic energy.
Electromedical Safety Standards
Electromedical devices like pacemakers pose safety risks. Manufacturers must comply with Essential Principles 9.2 and 12. They can either follow Australian or international standards like IEC 60601-1 or justify alternative compliance methods.
Connection to Public Mains
Devices that connect to the public mains must comply with AS/NZS 3112, 3551, and 3820, covering plug specifications and electrical safety requirements.
Electromagnetic Compatibility (EMC)
EMC is an important consideration, even for battery-powered devices. Risk analysis should guide EMC testing, which can follow standards like IEC 60601-1-2 clauses 7 and 8. Essential Principle 13.4 mandates EMC information in the device’s Instructions For Use (IFU).
Other Equipment and Telecommunications
Non-medical electrical equipment should also meet IEC and ISO EMC standards. Devices with telecommunications features must adhere to ACMA regulations, but electrical-only devices are exempt.
Radioactive and Radiating Devices
Radioactive devices fall under ARPANSA regulations, and radiating devices must comply with Essential Principle 11.
Programmed and Software Devices
Programmed devices must fulfill Essential Principle 12.1. Software devices need their own ARTG entry and must meet useability standards outlined in IEC 62304 and 62366, as well as Essential Principle 13 on labelling. Specifically Essential Principle 13B mandates that the software current version and build numbers are accessible and identifiable to users.
For more details, refer to the TGA guidance document: How the TGA regulates software based medical devices.
If you require further information, contact KD&A, we can support your organisation with your medical device compliance requirements.
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