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Medical device compliance with TGA consultants Australia expert support

Trusted TGA Consultants for ARTG Approvals & Compliance

Navigating Australia's regulatory framework for medical devices and IVDs can be overwhelming. That’s where Elexes’ experienced TGA consultants step in. From device classification to ARTG registration support, our team ensures your product meets all Therapeutic Goods Administration (TGA) requirements swiftly and accurately.

Whether you're a startup or an established manufacturer, we provide hands-on support for your TGA submissions, conformity assessments, and post-market obligations.

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Comprehensive TGA Compliance & ARTG Registration Support

Australia TGA conformity assessment for medical devices

Australia’s medical device market is one of the most regulated and respected globally. To legally supply a device or IVD, manufacturers must obtain ARTG inclusion, facilitated through TGA submissions and strict compliance with Therapeutic Goods (Medical Devices) Regulations 2002.

Our TGA regulatory consultants help you:

⦿ Identify correct device classification

⦿ Prepare technical documentation

⦿ Address Essential Principles

⦿ Complete TGA Conformity Assessments (direct or CE-leveraged)

⦿ Liaise with TGA on behalf of international manufacturers

Need help identifying the right regulatory pathway? Trust Elexes to bridge the gap between innovation and compliance.

Comprehensive TGA Regulatory Consulting Services Tailored to Your Needs

End-to-end TGA compliance services & ARTG submission support

Our support extends across the full Australian Medical Device Compliance lifecycle:

⦿ TGA strategy development

⦿ Device classification guidance

⦿ Conformity assessment planning (including CE reliance)

⦿ Preparation of technical documentation

⦿ Compilation and submission of TGA applications

⦿ Response to TGA queries and audit preparation

⦿ Appointing and coordinating with an Australian sponsor

For international manufacturers, Elexes ensures you meet TGA’s expectations while optimizing time and cost.

TGA Submission Checklist – Click here to download our expert-prepared guide to streamline your ARTG registration process.

Explore our IVD Regulatory Consulting and MDSAP services.

Read more about TGA's official guidance here.

Understand the TGA Submission Process & Pathways

Understand Your Regulatory Path with Clear Comparisons and Steps

Our infographics break down complex TGA procedures into simple, actionable steps for device and IVD manufacturers.

Comparison of TGA vs CE regulatory pathways
Step-by-step TGA submission and ARTG registration flow

FAQs

Frequently Asked Questions!

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A TGA consultant guides medical device manufacturers through Australia’s regulatory framework, including ARTG registration support, documentation, and TGA submissions services.

Yes, if you’re a foreign manufacturer, you must appoint an Australian sponsor to submit your application and liaise with the TGA.

Yes, CE certification can streamline TGA conformity assessment guidance under mutual recognition agreements, reducing approval time.

The TGA process duration varies depending on device class and documentation completeness, ranging from a few weeks to several months.

Expertise

Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.

Local Regulatory Certification

At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.

Confidentiality

We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.

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Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

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“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. “

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President ViDava, Florida

“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. “

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Linda Pan

Sr. Exe Treedental, Hong Kong

“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. “

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Joshua Mink

Manager Outset Medical, California

“Highly recommend Elexes! They always meet commitments and follow through on action items. “

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Michal Depa

CTO Jana Care, Massachusetts

“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. “

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Philip McFerran

MD Blackrock Pharma, England

“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. “

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VP Regulatory AliveCor, California

“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. “

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Elizabeth W

Owner Liz Inc., Arizona

“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. “

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CEO Radformation, New York

“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! “

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