The following pages contain information and guidance for manufacturers who intend to submit an application for TGA-issued Australian Conformity Assessment certificate.
Conformity Assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles.
From 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs) no longer require mandatory TGA Conformity Assessment certification.
Key information
-
PageGuidance and links to information on Conformity Assessment for medical devices.
-
Corporate reportsInformation on Conformity Assessment of in vitro diagnostic medical devices (IVDs).
-
FormsInformation and forms about applications for TGA Conformity Assessment certificates.
-
GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
-
GuidanceThis guidance outlines ARTG and Conformity Assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.
-
PageOur approach to delays in overseas and Australian Conformity Assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
-
Corporate reportsGuidance for reducing assessment fees for ARTG application audits and TGA conformity assessments of medical devices (including IVDs).
-
FormsInformation on when a manufacturer's statutory declaration is required.
Product types