Product & classification assessment
Clarify whether your product is a medical device, its likely classification and the regulatory questions that need closer review.
Australian medical-device market access
A clearer path to the Australian medical device market
Pacific Access Medical helps medical-device manufacturers and Australian sponsors understand TGA pathways, prepare for ARTG inclusion and approach market entry with confidence.
Australian-focused · Practical · Independent
From first question to market readiness
- 01Understand the productIntended purpose, device status and classification
- 02Choose the pathwayManufacturer evidence and ARTG inclusion route
- 03Prepare for AustraliaSponsor, application, labelling and supply
- 04Stay compliantPost-market duties and lifecycle changes
New specialist resource
Software & AI medical devices in Australia
Understand when health software may become a medical device, how intended purpose and risk shape classification, and what AI-enabled teams should plan for before market entry.
- 01Define the intended purpose
- 02Check device status, exclusions and exemptions
- 03Plan classification, evidence and lifecycle controls
Why Pacific Access Medical
Clear guidance for the decisions that shape an Australian pathway
- Australian pathway focusInformation centred on TGA requirements, ARTG inclusion and sponsor responsibilities.
- Practical decision supportStart with the questions that affect status, classification, evidence and market entry.
- Independent informationPlain-language guidance with clear limitations and links back to official sources.
What we help with
Regulatory support built around the decisions that matter
Start with a focused question or seek support across the complete Australian market-entry journey. The scope can be shaped around the product, evidence already held and the sponsor’s responsibilities.
ARTG inclusion pathway
Identify a practical Australian pathway based on the manufacturer, device class and available conformity assessment evidence.
Australian market entry
Understand sponsor responsibilities, application preparation, labelling, supply arrangements and launch-readiness requirements.
Ongoing compliance
Plan for post-market obligations, incident reporting, changes, annual charges and maintaining valid regulatory evidence.
Self-guided starting point
Explore your likely regulatory pathway
Use the three-step assessment to screen device status, estimate a preliminary classification and explore a possible evidence route.
Start assessmentLearn before you apply
Build your Australian regulatory knowledge
Read plain-language guidance on ARTG inclusion, sponsors, evidence, market supply and ongoing compliance, supported by official TGA links.
Browse resourcesLatest insights
Keep pace with Australian medical-device regulation
Read practical analysis of TGA changes, current guidance and the implications for manufacturers and sponsors.
Browse all insightsContact Pacific Access Medical
Tell us what you are trying to bring to Australia
Share a short description of the product, its intended purpose and the support you need. We will use that information to understand the most useful next step.
Pacific Access Medical detailsEmailinfo@pacificaccess.com.auLinkedInPacific Access Medical LocationSydney, NSW, AustraliaABN65 881 977 095