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Australian Register of Therapeutic Goods
TGA ARTG Inclusion Strategy & Application Preparation
ARTG inclusion is not a simple product-by-product registration. The application is built around the Australian concept of a “kind of medical device”, with classification, GMDN, manufacturer, conformity assessment evidence and grouping logic determining how devices are represented in the ARTG.
When This Support Is Needed
First ARTG inclusion for a manufacturer
Adding new models, families or variants to an existing product line
Assessing whether multiple products can sit under one ARTG inclusion
Correcting an existing ARTG entry that no longer matches the supplied product
Changing Sponsor or manufacturer information on the register
Preparing for application audit or preliminary-assessment questions
What We Challenge Before Submission
Grouping products that do not meet the same kind-of-device criteria
GMDN term that does not accurately represent intended purpose or technology
Mismatch between ARTG application and Declaration of Conformity
Manufacturer Evidence identifier that does not cover the proposed class / scope
Claims or model information in Australian labelling that exceed the ARTG regulatory basis
Our Support Includes
ARTG inclusion pathway assessment (Class I to III & IVD Class 1 to 4)
Kind-of-device and grouping strategy to optimize ARTG entries
GMDN term assessment and precision code selection
Manufacturer and Sponsor data alignment across all systems
Manufacturer Evidence linkage review and verification
Declaration of Conformity review and harmonization
Intended purpose and classification consistency review
Supporting documentation package compilation
TGA Business Services (TBS) application preparation and lodgement
Application audit / Request for Information (RFI) response support
ARTG entry quality check and certificate validation after inclusion
Senior Regulatory Question:
If TGA asks for the Declaration of Conformity, conformity evidence and technical dossier today, will every document support the same device scope represented by the ARTG application?
Submit Your ARTG Inclusion with Full Regulatory Defensibility
Our Australian regulatory consultants prepare TBS submissions, link Manufacturer Evidence, and manage TGA application reviews.