TGA and Regulatory Affairs Consultants for Medical Devices

Compliance Management Solutions works as TGA and regulatory affairs consultants for medical device, IVD and pharmaceutical companies. We help Australian manufacturers and distributors, and overseas manufacturers entering Australia, work out how their product is regulated, build the evidence the TGA expects, get it into the ARTG and keep it compliant once it is on the market.

Talk to a regulatory consultant Call +61 4 33 124 266

What TGA regulatory affairs involves

Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, unless they are exempt, excluded or otherwise authorised by the TGA. "TGA registration" is the phrase most people search for; for medical devices the TGA's own term is ARTG inclusion. Getting there is a chain of decisions, and an early mistake travels all the way down it:

Is it a therapeutic good? Some products are regulated as foods or cosmetics, and some are excluded or exempt.
How is it classified? Medical devices are classified by risk from Class I to Class III, and IVDs from Class 1 to Class 4. The class sets the evidence the TGA needs.
What evidence is needed? The manufacturer's Declaration of Conformity, and for all but the lowest-risk devices, conformity assessment certification from the TGA or a comparable overseas body.
Who is the sponsor? The Australian party that applies for inclusion and holds the ARTG entry.
The application. Lodged with the TGA, assessed, and possibly selected for audit.
Post-market obligations, which run for as long as the product is supplied.

Regulatory affairs is the work of getting each of those decisions right and in the right order, so the evidence is built for the pathway rather than retrofitted to it.

Our TGA and regulatory services

Each of the core services has its own page with the detail. In summary:

Australian TGA sponsor

We act as the official Australian sponsor for overseas manufacturers of medical devices, IVDs and medicinal products, so you can supply Australia without an Australian entity of your own. That covers ARTG inclusion support, regulatory submissions and direct communication with the TGA, then the post-market work that comes with the role. Read about our TGA sponsor service.

ARTG inclusion

For manufacturers and sponsors preparing an application, we support ARTG inclusion from classification and technical documentation through to the TGA submission and any application audit that follows. Read about ARTG inclusion support.

TGA conformity assessment

Conformity assessment evidence has to be in place before a device can be included, and it is often the longest step. We identify the procedure your device's class allows, prepare technical documentation and TGA conformity assessment dossiers, and get the quality system ready for audit. Read about TGA conformity assessment.

Regulatory strategy

The earlier the strategy is set, the less rework follows. Our regulatory strategy work covers:

regulatory pathway assessment, and device classification and jurisdiction analysis
market entry strategies for Australia, Europe, the United Kingdom, the United States and other markets
identification of the applicable standards and regulatory requirements
clinical evidence and documentation planning, and regulatory submission roadmaps
gap assessments and compliance planning

It also covers borderline products. For software, for example, we assess where it sits and identify the regulatory pathway that applies.

Technical documentation and clinical evidence

We develop regulator-ready technical files covering the device description, intended purpose, ISO 14971 risk management, labelling and IFU, and Essential Principles compliance, along with clinical evaluation reports and biocompatibility and biological evaluation reports. Our approach aligns with both TGA and EU MDR 2017/745 requirements.

Post-market compliance

Once a product is on the ARTG, the sponsor's post-market responsibilities begin. We support adverse event and vigilance reporting, complaint handling systems, CAPA management, post-market surveillance documentation, annual reporting obligations and technical documentation maintenance.

The ARTG

The ARTG is the public database of therapeutic goods that can be legally supplied in Australia, and anyone can search it. An entry records details such as the product name, the sponsor and the manufacturer, and for devices, the classification. Three points about it are worth knowing before you start:

Every ARTG entry belongs to a sponsor, which is responsible for applying for it and maintaining it. If the sponsor changes, the new sponsor must notify the TGA within three months.
Someone else's entry does not cover you. The TGA is clear that another company's ARTG entry does not make it legal for you to import or supply the same product, even if the manufacturer is the same.
How products are grouped into entries matters. Devices are included by kind of medical device, and getting the grouping right at the start avoids paying for entries you did not need.

Using approvals you already hold

Many devices reach Australia on the strength of an assessment already made overseas. The TGA recognises comparable overseas regulators and assessment bodies: EU notified bodies, the US FDA, Health Canada, MDSAP auditing organisations, Japan's MHLW and PMDA, Singapore's HSA and UK approved bodies. The evidence must be for the same device, with the same design, intended purpose and indications, and an MDSAP certificate has to show the manufacturer was assessed against the Australian regulations. Mapping what you already hold to the Australian pathway is usually our first piece of work.

Application audits and timeframes

Every device application goes through a preliminary assessment, which the TGA must complete within 20 working days. An application can then be selected for audit, and the TGA's current targets are:

Audit	TGA target timeframe
Level 1	50 working days
Non-mandatory Level 2 or IVD	150 working days
Mandatory Level 2 or IVD	180 working days

These targets include the preliminary assessment and exclude time spent waiting for your responses. The TGA does not publish a single end-to-end figure for inclusion, and neither do we. The most reliable way to shorten the process is a complete application at lodgement.

Beyond Australia

Many device companies sell into more than one market, and the evidence is best planned once. Alongside the TGA work:

United States: FDA 510(k), De Novo and PMA application preparation.
Quality systems: ISO 13485 implementation and MDSAP audit readiness.
New Zealand: Authorised New Zealand Agent services, including liaison with Medsafe.
Europe: EU Authorised Representative services under the MDR and IVDR.
Asia: registration and local representation in Thailand and Vietnam, South Korea (with our local partner) and India.

Medicines and other therapeutic goods

Our regulatory work is not limited to devices. We act as Australian sponsor for medicinal products, support TGA GMP implementation and maintenance for medicinal products, active pharmaceutical ingredients and sunscreens, including training, and help with evidence for complementary medicine indications. Our pharmaceutical GMP and GDP training supports teams on the manufacturing and distribution side.

How we work

A confidential conversation about the product, its intended purpose and the markets you want to enter.
Pathway assessment: classification, the evidence you already hold and what is missing.
Evidence and documentation, built for the pathway rather than retrofitted to it.
Submission, with direct communication with the TGA through assessment and any audit.
Ongoing compliance for as long as the product is supplied.

Our team has first, second and third-party medical device audit experience. Our director, George Loizou, has worked as a notified body and MDSAP auditing organisation lead auditor and as a notified body technical file reviewer, so we prepare documentation the way assessors read it. We work Australia-wide from our Melbourne head office, with offices in New Zealand, Europe, Malaysia and Singapore. The decision on any application rests with the TGA; our job is to make sure what it receives is right.

Start with a pathway review

Frequently asked questions

What does a TGA consultant do?

A TGA consultant helps a manufacturer or sponsor work out how a product is regulated in Australia and then prepares what the TGA needs to see: the classification, the conformity assessment evidence, the technical documentation and the ARTG application. Good regulatory affairs support continues after inclusion, because the sponsor carries post-market obligations for as long as the product is supplied.

Is TGA registration the same as ARTG inclusion?

In everyday use, yes. "TGA registration" is the common phrase, but for medical devices the TGA's own term is inclusion in the Australian Register of Therapeutic Goods (ARTG). Therapeutic goods must be entered in the ARTG before they can be lawfully supplied in Australia, unless an exemption or other TGA authority applies.

Can I search the ARTG to see whether a product is already registered?

Yes. The ARTG is a public database, and the TGA provides a search tool. An entry shows details such as the product name, the sponsor and the manufacturer. Note that another company's ARTG entry does not allow you to import or supply the same product, even if the manufacturer is the same. Every ARTG entry belongs to its sponsor.

Do overseas manufacturers need an Australian sponsor?

The sponsor is the person or company that imports, exports or manufactures the goods, or arranges for that to happen, and it is the sponsor who applies to include the goods in the ARTG. An overseas manufacturer without an Australian entity therefore supplies Australia through an Australian sponsor. We act as sponsor for overseas manufacturers of medical devices, IVDs and medicinal products.

How long does TGA registration take?

The TGA does not publish a single end-to-end timeframe. Every device application has a preliminary assessment, which the TGA must complete within 20 working days. If the application is selected for audit, the TGA's current targets are 50 working days for a Level 1 audit, 150 for a non-mandatory Level 2 or IVD audit and 180 for a mandatory Level 2 or IVD audit, and time spent waiting for your answers is not counted. Conformity assessment evidence often takes longer to put in place than the application itself.

Can we use our CE marking or FDA clearance in Australia?

Often, yes. The TGA recognises assessments from comparable overseas regulators and assessment bodies, including EU notified bodies, the US FDA, Health Canada, MDSAP auditing organisations, Japan's MHLW and PMDA, Singapore's HSA and UK approved bodies. The evidence has to be for the same device, with the same design, intended purpose and indications.

Can you guarantee our product will be included in the ARTG?

No one can. The decision on inclusion rests with the TGA. What we can do is make sure the classification is right, the evidence fits the pathway and the application is complete when it is lodged, which is what keeps questions and delays to a minimum.