Hepatitis B and C viruses IVD self-tests
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
November 29, 2023
Last updated
November 29, 2023
Description
Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV).
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)