Determinations for Australian conformity assessment bodies
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Legislation, Medical Devices Safety, In Vitro Diagnostic Medical Devices (IVDs)
Published
June 26, 2024
Last updated
June 26, 2024
Description
These guidelines assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)