Navigate TGA Medical Device Registration in Australia

A quick guide for manufacturers and innovators.

Entering the Australian Market

Australia presents exciting opportunities for medical device manufacturers and innovators. But entering the market isn’t just about having a great product, it’s about making sure it complies with local rules and regulations. This guide will walk you through the Therapeutic Goods Administration (TGA) registration process and how to get your device listed on the Australian Register of Therapeutic Goods (ARTG).

We’ll break down the key regulations, outline the step-by-step path to registration, and explain why appointing a local Australian Sponsor is essential.

Understanding the Regulatory Landscape

Therapeutic Goods Administration (TGA) is responsible for making sure that medical devices sold in Australia are safe, effective, and high quality.

To do this, they rely on several core regulations:

• Therapeutic Goods Act 1989 – the primary legislation setting out how therapeutic goods are regulated.
• Therapeutic Goods Regulations 1990 – details the day-to-day operational rules under the Act.
• Australian Regulatory Guidelines for Medical Devices (ARGMD) – helps manufacturers understand the process and obligations.
• Australian Standards – define the specific technical and performance requirements devices must meet.

Together, these create a framework that ensures public health is protected by only allowing safe, high-quality medical devices on the market.

Key Regulations to Consider

When preparing your device for the Australian market, keep these four pillars in mind:

• Classification Rules: Devices must be classified based on risk; higher-risk devices require more regulatory scrutiny.
• Essential Principles: These are core standards your device must meet, covering everything from design and safety to clinical evaluation.
• Conformity Assessment: You’ll need documented evidence showing that your device meets the Essential Principles.
• Labelling and Instructions for Use: Australian-specific labelling rules must be followed to ensure clarity and compliance.

Need-to-Know: Before You Apply

Did you know? In Australia, to be formally recognised as a manufacturer, the Therapeutic Goods Administration (TGA) must first accept your Manufacturer Evidence. This documentation demonstrates that your manufacturing processes meet the required quality and safety standards.

Once the TGA accepts this evidence, the manufacturer gains official recognition. From there, the appointed Australian Sponsor can submit an application to include the medical device on the Australian Register of Therapeutic Goods (ARTG), using the approved Manufacturer Evidence to support the device’s regulatory compliance.

Step-by-Step: How to Get ARTG Inclusion

The process of getting your device listed on the ARTG can seem complex, but broken down into steps, it’s manageable:

1. Classify your device – determine your device’s classification under TGA guidelines.
2. Appoint an Australian Sponsor – required if your company is based outside Australia.
3. Conduct a Conformity Assessment – gather evidence for safety and performance standards.
4. Prepare your application – includes certificates, evidence, and documentation.
5. Undergo TGA Evaluation – TGA reviews the sponsor’s application and evidence.
6. Receive ARTG inclusion – your device is listed, granting market access.

The Role of the Australian Sponsor

An Australian Sponsor is your regulatory partner. Their role includes:

• Acting as your local representative in Australia.
• Submitting applications on your behalf.
• Managing communication with TGA.
• Ensuring compliance throughout the product life cycle.

You cannot enter the Australian medical device market without one.

Choosing the Right Sponsor?

Not all sponsors are alike. When evaluating potential sponsors, look for:

• Regulatory expertise in your device category.
• A track record of successful ARTG inclusions.
• Ability to support post-market compliance.

ARTG Listing = Market Access

Once listed in the ARTG, your sponsor can import, distribute, and supply your product in Australia.

Timelines and Planning

Registration timelines vary depending on:

• Device risk classification.
• Availability of supporting documentation.
• TGA’s current workload.

For example, a low-risk device may be listed within weeks, while a higher-risk device may take months.

Planning ahead: working with a proactive sponsor helps streamline the process.

Leveraging Overseas Approvals

If your device is approved by trusted regulators (FDA or EU), you may be eligible for a streamlined TGA assessment.

Understanding the Special Access Scheme (SAS)

SAS allows access to unapproved medical devices for individual patients in special situations. It’s not a full market approval route but is valuable for urgent care or market testing.

Your Trusted Regulatory Partner: Stark Medical

Stark Medical is a well-established Australian Sponsor with deep experience in TGA device registration and compliance. We’re equipped to guide you through:

• Accurate device classification
• Tailored regulatory strategies
• Documentation and application preparation
• Ongoing compliance and post-market surveillance

With a solid understanding of TGA expectations and a proven track record, Stark Medical takes the uncertainty out of your regulatory journey.

Let’s Get Started

Ready to bring your medical device to the Australian market? We’re here to help.

Contact Stark Medical for a personalised consultation. Whether you're new to TGA regulation or ready to submit, we’ll work with you at every stage—from planning to full compliance.