Guideline on quality documentation for medicinal products when used with a medical device

About this guideline

Adopted by the TGA: 1 August 2025

Overseas effective date: 01 January 2022

Categories: Medical devices

TGA annotations: Nil

• Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
• All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia