TGA regulatory affairs consultants for Medical Devices & IVDs

Looking to launch your medical device or IVD in Australia? Partnering with a trusted TGA regulatory affairs consultant is the smartest way to ensure smooth, compliant, and timely market entry. At Elexes, we offer expert guidance on navigating the complex TGA regulatory landscape, from preparing submission dossiers to securing ARTG listings and maintaining post-market compliance. Our team brings a wealth of global experience, helping you avoid delays, reduce regulatory risks, and accelerate your path to commercial success in the Australian healthcare market.

Why do you need a TGA regulatory affairs consultant?

The Australian market for medical devices is fast-growing, and handling the regulatory landscape requires more than just reading the Australian medical device regulations. The TGA imposes serious standards for public safety. Regulatory lapses in strategy can cause delays, rejections, or worst-case scenario, legal consequences.

The Elexes team of TGA compliance experts will make life easier for you. Strategically advising you, preparing technical documentation, and seeing to the final approval of your medical devices and IVDs in a timely manner.


What We Bring to the Table:

⦿ Over a decade of global regulatory experience

⦿ Deep understanding of TGA and ARTG requirements

⦿ End-to-end submission and post-approval support

ARTG Submission & Compliance Services

We offer tailored regulatory services for all stages of your product lifecycle.

Team of TGA compliance consultants outlining TGA submission process and ARTG listing support.

Our experts help you maintain compliance through vigilance reporting, recalls (if needed), and ongoing TGA communication.

Don't have a local sponsor in Australia? We help you find a reliable TGA sponsor support to represent your product before the TGA.

We evaluate your device’s classification and determine the most efficient approval path based on conformity assessment requirements.

Whether it’s an application for inclusion on the ARTG or a Conformity Assessment Certificate, we ensure your dossier is complete and compliant.

Our TGA consultants help compile and review documentation, including Clinical Evidence Reports, Risk Management Files, and Essential Principles checklists.

How Our Consultants Guide You Through TGA Approval

At Elexes, we don’t take a one-size-fits-all approach. Each product is unique, and so is our strategy. Our TGA regulatory affairs consultants are ever so methodical and cooperative in ensuring that your medical device or IVD has met every applicable TGA requirement with utter clarity and confidence.

Here’s how we guide your product to successful compliance:

Initial consultation & gap assessment

We begin with an in-depth review of your product, current documentation, and regulatory needs. This helps us identify gaps early and outline a custom roadmap to TGA compliance.

Regulatory pathway mapping

Based on device classification and conformity evidence (e.g., CE, FDA, ISO 13485), we define the most efficient submission strategy, whether through mutual recognition or direct assessment.

Dossier preparation & sponsor coordination

Our team prepares or refines all required documents, including technical files, clinical evidence, and the Essential Principles checklist, and works closely with your sponsor for accurate submissions.

TGA submission & follow-up

We manage the entire submission process, respond to TGA queries, and track progress until approval. Our proactive communication ensures you’re always informed.

Post-approval compliance support

Once listed on the ARTG, we continue to support you with vigilance reporting, recalls (if needed), and regulatory updates to maintain long-term compliance. Our process is designed to save you time, reduce errors, and give you confidence at every step.

Who needs our TGA regulatory affairs consulting services?

Our services cater to a wide range of clients, including:

⦿ Medical Device and IVD Manufacturers (Domestic and International)

⦿ Contract Manufacturers and OEMs

⦿ Startups entering the Australian market

⦿ Legal Manufacturers looking for post-market support

⦿ Distributors seeking ARTG listings

Whether you’re launching a Class I surgical instrument or a high-risk diagnostic IVD, our TGA regulatory affairs consultants will ensure a smooth compliance journey.

TGA submission checklist: Are you ready for ARTG listing?

Medtech professionals discussing TGA regulatory pathways and ARTG listing needs

Global Regulatory Landscape & TGA Submission Roadmap

Gain clarity on how TGA compares with FDA and EU MDR, and navigate your TGA submission with ease.

Step-by-step TGA regulatory submission process flowchart

Our Expertise

Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Our Services

Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

img
img

We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

A Trusted Team of Consultants

Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.

Local Language
Auditor

Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.

Why Choose Elexes?

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.

Associated Regulatory Authorities.

img
We’ve More
Than 256+ Global Clients
The Best RA & QA Consultants

Clients Testimonials

Amazing Feedback About Our Services

Popular Clients

We’ve 200+ Global Premium Clients

Saneso
Niramai
Apex dental sensors
Neurasignal
SS inovations
Amaryllis
Inclode
iMedisync
DJOGlobal logo cmyk_TM
Summus Laser Logo

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img