Principle 3: Medical devices to be suitable for intended purpose
Information
Type
Page
Regulated products
Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
December 19, 2023
Last updated
July 10, 2024
Description
Principle 3 requires manufacturers to ensure their devices perform in the way intended. This includes the design, manufacturing process, and packaging.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)