Demonstrating compliance with the Essential Principles
Information
Type
Page
Regulated products
Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
August 25, 2022
Last updated
June 21, 2024
Description
Manufacturers are responsible for generating, collating, assessing, and maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)