Meet Freya
August 2024
“The updated Medical Devices Essential Principles Checklist provides key guidance for manufacturers to demonstrate compliance with safety and performance standards for medical devices. This document helps manufacturers identify essential safety requirements, maintain scientific and clinical evidence, and provide justification for each principle outlined.
Recent updates, as of August 22, 2024, addressed formatting and accessibility issues, making it easier for manufacturers to enter required data into tables. Links have also been added to direct users to relevant Therapeutic Goods Administration (TGA) web pages. Notably, a new ‘products’ line has been introduced, allowing manufacturers to specify the devices that the checklist applies to—helpful for those needing to complete multiple checklists.
Earlier updates included new instructions on filling out the checklist for new device applications and change requests. The manufacturer is required to provide detailed justifications for each compliance measure and reference documentation within their quality system.
The checklist now includes key sections such as device identification, intended purpose, user safety instructions, and patient information. Specific requirements for implantable and reusable devices are also outlined, including the provision of risk-related information and instructions on reuse. For software-based devices, version and build numbers must be clearly accessible.
This document serves as a comprehensive guide to ensure manufacturers meet all regulatory obligations in accordance with the essential principles for medical device compliance.”
Region: Australia
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