On March 26, 2025, Qualtech hosted a comprehensive webinar on the current landscape of medical device approvals in Australia. With participation from over a hundred regulatory professionals and manufacturers from regions including Southeast Asia, China, Taiwan, Japan, and several EU member states, the session provided practical insights into navigating the TGA’s regulatory system, from classification to post-market obligations.

 

Key Topics Covered

1. Introduction to TGA and Regulatory Framework

The webinar began with an overview of the Therapeutic Goods Administration (TGA), which regulates therapeutic goods including medical devices in Australia. The primary legislative references include:

• Therapeutic Goods Act 1989
• Therapeutic Goods (Medical Devices) Regulations 2002 (updated semi-annually)

 

Attendees were introduced to the relevant TGA branches such as:

• Medical Devices Authorisations Branch
• Medical Devices Surveillance Branch
• Laboratories Branch
• Manufacturing Quality Branch

 

2. Medical Device Classification

Devices in Australia are classified based on risk:

• Non-IVDs: Class I, IIa, IIb, III
• IVDs: Class 1, 2, 3, 4

Each class impacts the conformity assessment path, documentation, and fees. Common examples were provided for each class to help manufacturers assess their device risk levels correctly.

 

3. Stakeholders & Roles

• Sponsor: Must be based in Australia and is responsible for ARTG inclusion, communication with TGA, and post-market surveillance.
• Manufacturer: Handles design, production, QMS compliance, and labeling.
• Agent: Acts on behalf of the manufacturer or sponsor for regulatory submissions.

The importance of choosing a reliable and proactive sponsor was emphasized, particularly for post-approval support and recall handling.

4. ARTG Inclusion Process

The TGA registration process consists of three main steps:

1. Step 1: Manufacturer Evidence (ME)
   • Path 1 – Full Conformity Assessment (includes onsite audit)
   • Path 2 – Abridged Conformity Assessment (based on CE Mark, FDA 510(k), MDSAP, PMDA, etc.)

1. Step 2: Device Application (DA)
   • Audit selection based on device class
   • Level 1 and 2 audits for non-IVDs
   • Technical file review for IVDs

1. Step 3: ARTG Inclusion
   • Final approval for market entry and distribution

5. Fees & Charges

• Application Fees: Apply during initial registration and vary by device class and audit requirements. These are non-exempt.
• Annual Charges: Apply after ARTG inclusion. Exemptions may be granted for new entries or entries with zero turnover, provided a declaration is submitted.

6. Post-Market Responsibilities

Sponsors and manufacturers must ensure ongoing compliance with TGA requirements:

• Maintain device conformity
• Adverse event reporting (including overseas events)
• Product recalls and corrective actions
• Recordkeeping: Minimum 5 years after last manufacture

For Class IIb implantable and Class III devices, annual PMS reports are mandatory for the first three years.

7. Recalls and PRAC (Product Recalls, Alerts, Corrections)

A structured recall process was detailed:

• Gather product and distribution information
• Submit documentation via TGA eBusiness Portal
• DO NOT contact customers before TGA approval
• Follow-up reporting: Interim (6 weeks), Close-out (12 weeks)

Market actions are classified by Class (1–3), Type (Recall, Correction, Alert, Quarantine), and Level (Wholesale to Consumer).

8. UDI (Unique Device Identification) Regulations

TGA has released a draft UDI guidance in Dec 2024. Key points:

• Applicable to non-IVDs (Class I–III) and IVDs (Class 1–4)
• Must use issuing agencies: GS1, HIBC, ICCBBA
• Human Readable + AIDC format required
• Upload to AusUDID
• Compliance to begin with high-risk devices; dates TBD

9. Frequently Asked Questions

• Are audits mandatory? Only certain device types are mandated; others may be selected randomly.
• Can product names differ by country? Yes, but supporting documents must prove it’s the same device.
• Can devices be stored overseas before import? Yes, as long as labeling requirements are met.
• Do distributors need sponsor authorization? No, but both parties must keep clear distribution records.
• Can we import demo units before ARTG? Yes, with proper labeling (e.g., “Not for human use”, “For Training or Display Purposes ONLY”).

Key Takeaways

1. Get the Classification Right – Risk class affects everything: cost, timeline, audit level.
2. Leverage Existing Approvals – CE, MDSAP, FDA can streamline registration.
3. Be Audit-Ready – Technical docs should be complete before submission.
4. Label Properly – Manufacturer and sponsor details must be on the packaging.
5. Stay Proactive – Regulations change frequently; maintain open communication with your sponsor and TGA.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you're a local startup or an international enterprise, we’re here to navigate regulatory complexity and accelerate your market access across Australia and the Asia-Pacific region.

Stay tuned for our upcoming webinars, including a deep dive into Clinical Trial Requirements in Australia later this year.

 

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