The TGA's approach to delays in medical device conformity assessment recertification
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Manufacturing, In Vitro Diagnostic Medical Devices (IVDs)
Published
June 28, 2023
Last updated
June 28, 2023
Description
Our approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)