TGA (Australia) & Medsafe (New Zealand) โ Medical Device Regulators
The Therapeutic Goods Administration (TGA) regulates medical devices in Australia under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. All medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before commercial supply. Foreign manufacturers must appoint an Australian Sponsor โ an entity with a physical presence in Australia โ to apply for and hold ARTG inclusions.
Australia classifies devices into Class I, IIa, IIb, III, and AIMD (Active Implantable Medical Device). Class I devices require manufacturer self-certification; Class IIa, IIb, III, and AIMD devices require Conformity Assessment Bodies (CABs) certification (such as CE mark recognition) and TGA review. TGA has strong mutual recognition arrangements with CE and FDA that can be leveraged for abridged assessment.
New Zealand is covered under the Trans-Tasman Mutual Recognition Arrangement (TTMRA). Devices included in the ARTG are generally recognized by Medsafe (NZ) and can be supplied in New Zealand without separate registration โ making Australia the natural entry point for the combined AU/NZ market.
- All devices must be included in the ARTG before supply in Australia
- Australian Sponsor with AU address required โ foreign manufacturers cannot self-apply
- CE mark or FDA clearance supports abridged TGA assessment pathway
- ARTG inclusion automatically enables NZ supply under TTMRA
- Post-market vigilance, recall procedures, and annual reporting required
TGA ARTG Inclusion Timelines by Device Class
Target processing times from application submission โ AU Sponsor appointment can run in parallel.
Integrated Services for TGA & Medsafe Registration
TGA ARTG Inclusion
End-to-end ARTG inclusion management for Class IโAIMD โ conformity assessment coordination, ARTG application preparation, abridged pathway assessment (CE/FDA), TGA query response, and ARTG registration maintenance.
Australian Sponsor
JNPMEDI APAC coordinates Australian Sponsor appointment โ the Australia-resident entity required to hold ARTG inclusions. Includes Sponsor agreement, compliance obligations management, and ongoing ARTG variation and renewal support.
NZ Medsafe & TTMRA
New Zealand market access via the Trans-Tasman Mutual Recognition Arrangement (TTMRA) โ leveraging ARTG inclusion for Medsafe NZ recognition. Covers TTMRA application, compliance notification, and ongoing NZ post-market obligations.
Why JNPMEDI APAC for Australia & NZ TGA Registration
Australia's TGA ARTG inclusion is the gateway to both markets. Under TTMRA, Medsafe NZ recognizes ARTG-listed devices โ eliminating the need for a separate NZ registration process. JNPMEDI APAC manages the combined AU/NZ program under a single engagement, ensuring complete Trans-Tasman coverage efficiently.
TGA has strong recognition arrangements with CE (MDR/IVDR) and FDA clearances. Devices with existing CE or FDA approvals can qualify for abridged TGA assessment, significantly reducing review time and documentation requirements. Our team assesses eligibility and prepares the supporting comparative analysis required for this pathway.
Australia is a high-income, English-language market with a well-funded public health system (PBS/MBS) and strong private hospital sector. Premium device pricing and high clinical adoption rates make it strategically important for global device manufacturers โ despite the relatively smaller population compared to Asian markets.
Australia TGA Registration โ FAQ
Yes. All ARTG inclusions for medical devices require an Australian Sponsor โ a legal entity with a place of business in Australia that takes regulatory responsibility for the device. Foreign manufacturers cannot self-apply for ARTG inclusion. JNPMEDI APAC coordinates Australian Sponsor appointment through our Australia partner network and manages all associated TGA compliance obligations.
Yes. TGA has a formal reliance pathway for devices with CE marking under EU MDR/IVDR or FDA clearance/approval. Eligible devices may qualify for abridged assessment โ TGA reviews the conformity assessment rather than conducting an independent full review. This pathway is applicable to Class IIa, IIb, and III devices and can reduce total assessment time by 40โ60% compared to a standalone TGA application.
Not automatically, but through the Trans-Tasman Mutual Recognition Arrangement (TTMRA), devices included in the ARTG can be supplied in New Zealand after notification to Medsafe NZ. TTMRA significantly simplifies NZ market access โ a separate full Medsafe registration is generally not required for ARTG-listed devices. JNPMEDI APAC manages the combined AU/NZ compliance program as part of our Australia market entry service.
The Australian Register of Therapeutic Goods (ARTG) is the official database of all therapeutic goods approved for supply in Australia. "ARTG inclusion" is the correct term for medical device market authorization โ devices are "included" in the ARTG (not "registered" as with pharmaceuticals). Each ARTG inclusion has a unique ARTG ID. JNPMEDI APAC manages the full ARTG inclusion process, from application through ongoing compliance maintenance and annual charge management.