--- title: "TGA, Therapeutic Goods Administration | MedTech Terms" description: "Australia's regulator for therapeutic goods including medical devices and IVDs. Plain-English Regulatory definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/tga#term", "name": "Therapeutic Goods Administration", "alternateName": "TGA", "description": "The TGA administers the Therapeutic Goods Act 1989, including the Australian Register of Therapeutic Goods (ARTG). 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[Regulatory](/terms?cat=Regulatory) 6. / 7. Therapeutic Goods Administration [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)TGA # Therapeutic Goods Administration Australia's regulator for therapeutic goods including medical devices and IVDs. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The TGA administers the Therapeutic Goods Act 1989, including the Australian Register of Therapeutic Goods (ARTG). Devices are classified I, IIa, IIb, III, or AIMD using rules aligned with the EU framework. What the regulation says The Therapeutic Goods Administration (TGA) is Australia's regulatory body for therapeutic goods, including medical devices. It operates under the Therapeutic Goods Act 1989, ensuring that medical devices supplied in Australia are [safe](/terms/safe-note) and perform as intended; this aligns with international regulatory principles for medical device oversight. ## What this means in practice TGA accepts certain overseas conformity assessments (e.g., EU [MDR](/terms/mdr-reporting) CE certificates from designated bodies, [MDSAP](/terms/mdsap)). Sponsors must hold the ARTG entry and meet Australian [Unique Device Identification](/terms/udi) (UDI) requirements as they roll out. ## Examples - A European manufacturer with a Class IIb device holding a valid EU MDR CE certificate can leverage this certification to support their application for ARTG inclusion with the TGA. - A US-based company seeking to introduce a new Class III implantable device in Australia must ensure it meets TGA's classification criteria and undergoes the appropriate conformity assessment procedures for ARTG entry. - A medical device sponsor in Australia needs to ensure their device information, including UDI, is accurately maintained on the ARTG once registration is achieved. Common pitfalls - • A common pitfall is misunderstanding the specific classification rules used by the TGA, which, while aligned with the EU framework, may have national nuances. - • Manufacturers sometimes fail to properly navigate the process of obtaining and maintaining an entry in the Australian Register of Therapeutic Goods (ARTG). - • Assuming that EU CE certification automatically guarantees market access in Australia without further TGA specific requirements is a frequent mistake. - • Not staying updated on the evolving Australian Unique Device Identification (UDI) requirements can lead to non-compliance. ## Frequently asked questions What is the Australian Register of Therapeutic Goods (ARTG)? The ARTG is a public database of all therapeutic goods, including medical devices, that can be legally supplied in Australia. Devices must be listed on the ARTG to be marketed in the country. How does the TGA classify medical devices? Does the TGA accept overseas conformity assessments? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi)[ Quality & Risk Medical Device Single Audit Program(MDSAP) Single audit of a manufacturer's QMS satisfying multiple participating regulators. ](/terms/mdsap) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 TGA· 1 IMDRF· 1 RAPS· 1 1. [1 TGA Medical Devices Verified TGA · tga.gov.au ](https://www.tga.gov.au/products/medical-devices) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym TGA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=tga) Learn in 60 seconds Card Lesson Quiz Australia's regulator for therapeutic goods including medical devices and IVDs. - · TGA accepts certain overseas conformity assessments (e.g., EU MDR CE certificates from designated bodies, MDSAP). - · Sponsors must hold the ARTG entry and meet Australian Unique Device Identification (UDI) requirements as they roll out. - · Devices are classified I, IIa, IIb, III, or AIMD using rules aligned with the EU framework. Remember this Watch out: A common pitfall is misunderstanding the specific classification rules used by the TGA, which, while aligned with the EU framework, may have national nuances. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [Unique Device Identification(UDI) ](/terms/udi) You may also need Auto-suggested from Regulatory and shared keywords. - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [National Medical Products Administration(NMPA) ](/terms/nmpa) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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