Australia TGA Medical Device Registration Service
Support for Australian medical-device market access, from product classification and conformity evidence to TGA submission and ARTG inclusion. The service can be scoped for Class I through higher-risk devices and special-material categories.
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Service Overview
EXIMIO can support manufacturers preparing devices for entry into the Australian market by organizing classification, conformity-assessment evidence, technical documentation and the TGA/ARTG application workflow. The source diagram branches by Class I status, manufacturing location and special-material conditions.
Process Flow & Timing
Select a route below to view the workflow and timing.
TGA / ARTG Registration
Indicative source timeline~1 month some Class I · ~2–3 months other routesSource estimate; not statutory
TGA Registration
Product Classification
Class I — Non-Sterile / Non-Measuring
Technical Documentation
Declaration of Conformity
Australian Sponsor / Authorization
TGA eBS / ARTG Application
ARTG Inclusion Certificate
Other Class I — Australian Manufacture
Conformity-Assessment Documentation
TGA Conformity-Assessment Certificate
Declaration of Conformity
TGA eBS / ARTG Application
ARTG Inclusion Certificate
Other Class I — Overseas Manufacture
Technical Documentation
Overseas Conformity Evidence
Declaration of Conformity
TGA Technical Review if Applicable
TGA eBS / ARTG Application
ARTG Inclusion Certificate
Higher-Risk / Special-Material Route
Conformity-Assessment Documentation
TGA Conformity-Assessment Certificate
Declaration of Conformity
TGA eBS / ARTG Application
ARTG Inclusion Certificate
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
LawTherapeutic Goods Act 1989Primary Australian therapeutic-goods statute governing ARTG supply framework.Open official source ↗LawTherapeutic Goods (Medical Devices) Regulations 2002Current medical-device regulations on the Australian Federal Register of Legislation.Open official source ↗Official GuidanceTGA Medical Device Inclusion ProcessOfficial steps for including medical devices and IVDs in the ARTG.Open official source ↗
Related Regulatory Support
Classification review, conformity-evidence planning, technical-document preparation and Australian sponsor coordination can be included as needed.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.