IVD medical devices regulation basics
Related information
- Overview of the regulatory framework for in-vitro diagnostic medical devices
Provides an overview of how in vitro diagnostic medical devices are regulated in Australia - Guidance for IVD sponsors - a roadmap to market
Presents an overview of the requirements for supplying an IVD under the new regulatory framework - Regulation of IVDs: laboratory-specific information
Information for laboratories about in vitro diagnostic medical devices - IVD medical devices: Definitions & links
Definitions of terms and links to other information about the regulation of IVDs - The regulation of nutrigenetic tests in Australia
Dependant upon the claims made by the manufacturer of each test, nutrigenetic tests are considered to be therapeutic goods and therefore must comply with the requirements of the Therapeutic Goods Act 1989