Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the safety and effectiveness of medical devices that utilize biological materials. This guidance is critical to the regulatory framework ensuring that medical devices incorporating such materials meet stringent safety and performance standards.
"13B" denotes a particular aspect or subcategory within Principle 13, focusing specifically on the safety and performance criteria for medical devices that incorporate materials of biological origin.
It mandates that such devices must be designed and manufactured to ensure their safety and effectiveness, particularly in preventing potential risks associated with biological materials. These risks include immunological responses, disease transmission, and other biological hazards.
As part of the regulatory process for supplying medical devices in Australia, sponsors or manufacturers are required to demonstrate that their devices meet the relevant Essential Principles (EPs) for safety, quality, and performance. Software developers are considered manufacturers for regulatory purposes when their products are regulated medical devices.
There are 6 general EPs (Essential Principles checklist) that apply to all medical devices, and there are a further nine EPs. They relate to design and construction that apply to medical devices on a case-by-case basis.
In order to meet EP13B requirements, transition arrangements were made available for medical devices already included in the ARTG, all medical device software must be compliant by November 2024, and Sponsors should be aware that EPs 12.1 and 13.2(3) do not offer transition arrangements since these changes clarified existing requirements and did not introduce any new ones.
EP 13B requires manufacturers of software, or medical devices that incorporate software, to make the current software version number and build number (where applicable) accessible and identifiable to users. For further details on Essential Principle 13B and the regulatory requirements for medical devices containing biological materials, refer to the full guidance document on the TGA's website: Essential Principle 13B Guidance.
Also, the TGA updated the "Regulation of software-based medical devices" on 26th July 2024 to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.
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