Strategic, regulatory, financial and operational expertise for devices, diagnostics & digital health
Australia’s medtech sector operates in a highly regulated environment—TGA/ARTG pathways, ISO 13485 quality systems, clinical evidence, data privacy, and complex distributor models. Abdera helps local innovators and global entrants navigate this complexity so you can focus on R&D, market access and scale.
How Abdera Adds Value Across the Medtech Lifecycle
| Your Challenge | How Abdera Helps | Typical Outcomes |
|---|---|---|
| Entering the Australian market | Company setup, resident director, TGA sponsor support, ARTG inclusion, local tax & ASIC compliance | Faster, fully-compliant launch with clear regulatory roadmap |
| Pre-revenue cash runway | Virtual CFO modelling, R&D Tax Incentive claims, grant applications | Extended runway and non-dilutive funding pathways |
| Hiring regulated roles | End-to-end payroll & HR, Fair Work compliance, onboarding for clinical/technical staff | Accurate payroll, reduced HR admin, lower compliance risk |
Core Services for Medtech Clients
1. TGA Sponsor Services
All therapeutic goods imported into or supplied in Australia must have an Australian Sponsor listed on the ARTG. The Sponsor is legally responsible to the TGA for:
- Compliance with Australian therapeutic goods legislation.
- Holding and maintaining technical documentation.
- Adverse event monitoring and post-market vigilance reporting.
- Ensuring correct labelling, advertising and product claims.
A Sponsor can be independent of your distributor, this separation protects your regulatory position and provides continuity of supply.
At Abdera we offer to establish your Australian entity that becomes the TGA Sponsor.
2. Resident Director Services
Foreign-owned medtech entities must appoint at least one Australian-resident director. Abdera supplies experienced resident directors who understand TGA obligations, ARTG maintenance, ISO 13485 expectations, and state health regulations.
3. Turn-Key Company Services
- ASIC registration, ABN/TFN/GST setup
- TGA sponsor support and ARTG inclusion management
- State revenue registrations (payroll tax, stamp duty, land tax as relevant)
- Bank introductions and device-friendly merchant/onboarding
- Light-touch governance framework tailored to regulatory audits
4. Accounting & Compliance
- Monthly bookkeeping and management accounts (cost centres by product/class)
- Inventory costing for devices/consumables; landed-cost and COGS transparency
- BAS, FBT, income tax returns and transfer-pricing documentation support
- R&D Tax Incentive preparation for devices, diagnostics and software as a medical device (SaMD)
5. Virtual CFO Services
- Scenario modelling for submissions, trials and launch timelines
- Grant and concessional-funding applications; audit support
- Board reporting, KPI dashboards (burn, CAC/LTV, gross margin, PMS metrics)
- Pricing, rebate and distributor margin analysis
6. Payroll & HR Support
- Award interpretation and employment contracts for clinical/technical roles
- STP reporting, superannuation, WorkCover/return-to-work compliance
- Recruitment and onboarding (background checks, credentialing, inductions)
- Policies for travel to clinical sites and device handling
7. Embedded HR Advisory
- Workplace policies for WHS (labs, warehousing), complaint handling and vigilance
- Performance frameworks for field clinical staff and sales teams
- Visa sponsorship guidance for biomedical engineers, QA/RA specialists and clinical roles
Industry Credentials
- 20+ years supporting medical device, diagnostics and digital health companies entering or scaling in Australia
- Experience across TGA sponsor support, ARTG inclusion and post-market compliance
- Networks across distributors, clinical trial partners, accelerators and specialist advisers
Ready to accelerate market access?
Abdera can act as your compliance backbone, growth adviser and on-the-ground representative—so you can concentrate on innovation, evidence and adoption.
📞 Call us on +61 2 8916 6259
✉️ Book a discovery call via our contact page