Application requirements for medical devices - preliminary assessment
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Published
March 28, 2022
Last updated
March 28, 2022
Description
Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)