Question 1

How do I register a medical device with the TGA?

Accepted Answer

To register a medical device with the TGA you must classify the device under the Australian risk framework, appoint an Australian Sponsor, hold acceptable conformity assessment evidence (such as an EU CE certificate or TGA Conformity Assessment Certificate), demonstrate compliance with the Essential Principles, and submit an application for inclusion on the ARTG. Servi-Star manages this entire TGA medical device registration process on your behalf, from classification through to ARTG inclusion.

Question 2

What is the ARTG and do I need to be listed on it?

Accepted Answer

The ARTG (Australian Register of Therapeutic Goods) is the official database of therapeutic goods that can legally be supplied in Australia. With very limited exceptions, any medical device or IVD sold in Australia must be included on the ARTG. If you intend to import, export, or supply a medical device in Australia, you almost always need to be listed on the ARTG before you can place the product on the market.

Question 3

How long does TGA medical device registration take?

Accepted Answer

Timeframes vary by device class. Lower-risk Class I devices with complete documentation can be included on the ARTG relatively quickly, often within a few weeks, while higher-risk devices (Class IIb, III, and Active Implantable) that require TGA conformity assessment review can take several months. Preparing complete, well-structured technical documentation up front is the single biggest factor in avoiding delays, which is where working with an experienced TGA registration consultant pays off.

Question 4

How much does TGA registration cost?

Accepted Answer

TGA registration costs include TGA application and assessment fees plus an annual ARTG charge, and these scale with device classification and whether conformity assessment review is required. On top of TGA government fees there may be consulting costs to prepare documentation and manage the submission. We provide a transparent, fixed-scope quote after a free assessment so you understand the full cost of bringing your device to the Australian market before you commit.

Question 5

What's the difference between Class I, IIa, IIb, and III medical devices in Australia?

Accepted Answer

Australia uses a risk-based classification system aligned with international frameworks. Class I is lowest risk (e.g. many non-sterile, non-measuring devices), Class IIa is low-medium risk, Class IIb is medium-high risk, and Class III is highest risk (often devices that interact with the central circulatory or nervous system). The higher the class, the more evidence and TGA scrutiny is required, and Class IIb and III typically require TGA conformity assessment review before ARTG inclusion.

Question 6

Do IVDs have different TGA registration requirements than medical devices?

Accepted Answer

Yes. In Vitro Diagnostic (IVD) medical devices have their own four-tier classification (Class 1 to Class 4) based on public health and individual risk, and they require performance evaluation evidence (analytical and clinical performance) rather than the clinical evidence typical of therapeutic devices. IVDs also have specific labelling and documentation requirements, so an IVD regulatory strategy should be developed separately from a general medical device pathway.

Question 7

Can I sell a CE-marked device in Australia without TGA approval?

Accepted Answer

No. A CE mark alone does not permit supply in Australia. However, your existing EU CE certificate and technical documentation can often be used as acceptable conformity assessment evidence to support a faster ARTG inclusion. You still need an Australian Sponsor and must have the device included on the ARTG before you can legally supply it in Australia.

Question 8

What documents do I need for ARTG inclusion?

Accepted Answer

Typical documentation for ARTG inclusion includes evidence of conformity assessment (e.g. CE certificates or a TGA Conformity Assessment Certificate), a Declaration of Conformity, technical documentation demonstrating compliance with the Essential Principles, risk management and clinical or performance evaluation evidence, labelling and Instructions for Use, and details of your Australian Sponsor. We run a documentation gap analysis so you know exactly what is required before submission.

Question 9

What is an Australian Sponsor and do I need one?

Accepted Answer

An Australian Sponsor is the legal entity, based in Australia, that submits the ARTG application and holds the ARTG entry on behalf of the manufacturer. Any overseas manufacturer supplying a medical device or IVD in Australia must have an Australian Sponsor, as the TGA requires a local, accountable point of contact for regulatory obligations.

Question 10

Can a consultant act as my Australian Sponsor?

Accepted Answer

Yes. Servi-Star provides Australian Sponsor and in-country representation services, acting as your legal Sponsor for ARTG entries so you do not need to establish your own Australian entity. This is a common and efficient route for international manufacturers, and we manage all in-country obligations including TGA liaison, adverse event reporting, and recall coordination.

Question 11

What are the legal obligations of an Australian Sponsor?

Accepted Answer

An Australian Sponsor is responsible for holding the ARTG entry, maintaining conformity assessment evidence, reporting adverse events to the TGA, coordinating recalls and field safety corrective actions, retaining distribution records, paying the annual ARTG charge, and responding to TGA requests. The Sponsor is the TGA's primary point of accountability for the ongoing compliance of the device in Australia.

Question 12

Do overseas manufacturers need a local representative to sell in Australia?

Accepted Answer

Yes. Overseas manufacturers cannot hold an ARTG entry directly and must appoint an Australian-based Sponsor (local representative) to supply their device in Australia. Using an experienced third-party Sponsor like Servi-Star lets you enter the Australian market quickly without incorporating a local subsidiary or hiring local regulatory staff.

Question 13

How do I bring a medical device to market in Australia?

Accepted Answer

Bringing a medical device to market in Australia involves determining the correct classification, appointing an Australian Sponsor, assembling conformity assessment and Essential Principles evidence, preparing compliant labelling, and obtaining ARTG inclusion. A clear regulatory strategy at the outset avoids rework and delays. Servi-Star builds a step-by-step market entry roadmap tailored to your device and commercial timeline.

Question 14

What's the regulatory pathway for a new IVD in Australia?

Accepted Answer

A new IVD is classified from Class 1 to Class 4 based on risk, then requires performance evaluation evidence, technical documentation, and (for higher classes) TGA conformity assessment before ARTG inclusion. In-house IVDs (laboratory-developed tests) follow separate arrangements. We define the specific IVD regulatory pathway and evidence requirements for your product early so there are no surprises.

Question 15

How does TGA regulation compare to the EU MDR/IVDR?

Accepted Answer

The TGA framework is closely aligned with the EU MDR and IVDR, which means much of your existing EU technical documentation and conformity assessment evidence can be leveraged for the Australian market. There are important differences, however, in classification rules, the Essential Principles versus GSPR, Australian-specific labelling, and the mandatory Australian Sponsor requirement. We map your EU dossier against Australian requirements to identify exactly what needs to change.

Question 16

What changes do EU manufacturers need to make for Australian compliance?

Accepted Answer

EU manufacturers typically need to appoint an Australian Sponsor, confirm Australian classification (which can differ from the EU), align documentation with the Australian Essential Principles, adjust labelling and Instructions for Use for the Australian market, and set up TGA-compliant post-market surveillance and adverse event reporting. Servi-Star specialises in helping EU medical device and IVD manufacturers make this transition efficiently.

Question 17

Do I need a new regulatory strategy for each country I sell in?

Accepted Answer

Each market has its own regulator and requirements, so you do need a country-specific strategy, but you do not need to start from scratch. A well-structured global dossier can be adapted market by market. For Australia specifically, we build on your existing EU or other approvals to create an efficient, Australia-focused regulatory strategy rather than duplicating work.

Question 18

What quality management system do I need for TGA compliance (ISO 13485)?

Accepted Answer

For most medical devices, manufacturers are expected to operate a quality management system certified to ISO 13485, which the TGA accepts as evidence of manufacturing quality. Your QMS must cover design control, risk management, production and process controls, CAPA, and post-market activities. We assess your existing ISO 13485 system against TGA expectations and close any gaps.

Question 19

How do I prepare for a quality system audit?

Accepted Answer

Preparation involves reviewing your quality documentation, verifying that procedures match actual practice, ensuring CAPA and complaint handling records are complete, confirming design and risk management files are current, and conducting a mock audit to surface findings before the assessor does. Servi-Star runs internal and pre-assessment audits so you enter your certification or TGA audit with confidence.

Question 20

What's involved in an internal QMS audit for medical devices?

Accepted Answer

An internal QMS audit systematically reviews your quality system against ISO 13485 and applicable regulatory requirements, covering design controls, supplier management, production, CAPA effectiveness, complaint handling, and management review. The output is a prioritised findings report with practical corrective actions. We conduct independent internal audits that satisfy your QMS requirement for objective, competent auditing.

Question 21

What are TGA labelling requirements for medical devices?

Accepted Answer

TGA labelling requirements are set out in the Essential Principles and require that labels and Instructions for Use provide the information needed to use the device safely, identify the manufacturer and Australian Sponsor, and include relevant warnings, expiry, batch/serial details, and any required symbols. Labelling must be in English. We conduct full labelling reviews to confirm compliance before you supply into Australia.

Question 22

What are the Essential Principles for medical device labelling?

Accepted Answer

The Essential Principles are the fundamental safety and performance requirements a device must meet to be supplied in Australia, and several relate directly to the information supplied with the device, its labelling, and Instructions for Use. They ensure users have the information needed to use the device safely and identify it and its manufacturer. Our labelling reviews map each label element against the relevant Essential Principle.

Question 23

Do IVD labels need to be different for the Australian market?

Accepted Answer

Yes. IVD labelling must meet Australian-specific requirements, including English-language content, identification of the Australian Sponsor, intended purpose, and IVD-specific information such as performance characteristics and, where relevant, that a result requires confirmation. We review IVD labelling and Instructions for Use against Australian requirements to avoid compliance issues at supply.

Question 24

What are TGA post-market surveillance obligations?

Accepted Answer

Once a device is on the ARTG, the Sponsor and manufacturer must monitor its safety and performance in the market, maintain a post-market surveillance system, report adverse events, keep distribution records, and take corrective action when issues arise. The TGA can also request post-market information at any time. We help establish and run compliant post-market surveillance systems that meet these obligations.

Question 25

How do I report an adverse event to the TGA?

Accepted Answer

Adverse events involving medical devices must be reported to the TGA by the Australian Sponsor within defined timeframes that depend on the severity and nature of the event. Reports are submitted through the TGA's reporting channels and must include specified information about the device and the event. As your Sponsor, Servi-Star can manage adverse event assessment and reporting on your behalf.

Question 26

What happens if I don't meet post-market compliance requirements?

Accepted Answer

Failing to meet post-market obligations can lead to TGA enforcement action, including ARTG cancellation or suspension, recalls, fines, and reputational damage, and it can jeopardise your ability to supply in Australia. Proactive, well-documented post-market surveillance is the best protection. We help you put robust systems in place so compliance is maintained continuously rather than reactively.

Question 27

Do I need to renew my ARTG listing?

Accepted Answer

ARTG entries do not expire like a licence, but they are subject to an annual ARTG charge that must be paid each year to keep the entry active, and the entry must be kept accurate and up to date. Failure to pay the annual charge can result in the entry being cancelled. As your Sponsor we manage annual ARTG charge payment and keep your entries current.

Question 28

How do I find a medical device regulatory consultant in Australia?

Accepted Answer

Look for an Australian regulatory affairs consultant with proven TGA and ARTG experience, familiarity with your device type (medical device or IVD), and the ability to also act as your Australian Sponsor if needed. Servi-Star Australia is a specialist medical device regulatory consultancy with over 40 years of experience helping local and international manufacturers navigate TGA registration.

Question 29

How do I choose a TGA regulatory affairs consultant?

Accepted Answer

Choose a TGA regulatory affairs consultant based on demonstrated ARTG registration experience, relevant device and IVD expertise, transparent fixed-scope pricing, clear communication, and whether they can support the full lifecycle including Australian Sponsorship and post-market compliance. A free initial assessment is a good way to gauge their expertise and fit before you commit.

Question 30

How much does a regulatory consultant charge?

Accepted Answer

Regulatory consulting fees vary with the complexity of the device, its classification, and the scope of work, and may be quoted as a fixed project fee or on a retainer basis for ongoing Sponsorship and post-market support. Servi-Star provides transparent, fixed-scope quotes after a free assessment so you know your costs upfront, separate from TGA government fees.

Question 31

Do I need a regulatory consultant or can I do TGA registration myself?

Accepted Answer

You can manage TGA registration in-house if you have the regulatory expertise and time, but many manufacturers, especially those new to the Australian market, find a consultant faster and lower-risk because it avoids costly documentation errors, rejected applications, and delays. A consultant also provides the Australian Sponsor role that overseas manufacturers require, which cannot be self-performed from abroad.

Question 32

Do you provide regulatory consulting for small manufacturers?

Accepted Answer

Yes. Servi-Star works with manufacturers of all sizes, including small and emerging medical device and IVD companies that do not have in-house regulatory teams. We offer right-sized, fixed-scope support so smaller manufacturers can access the same expertise as large companies without maintaining a full regulatory department.

Question 33

Do you offer IVD regulatory consulting in Australia?

Accepted Answer

Yes. We provide specialist IVD regulatory consulting in Australia, covering IVD classification, performance evaluation, technical documentation, IVD-specific labelling, and ARTG inclusion, as well as ongoing Australian Sponsorship for IVD manufacturers. IVDs have distinct requirements from other medical devices, and our team has deep experience across both.

TGA & ARTG Registration Questions Answered

TGA & ARTG Registration Basics

Regulatory Strategy & Market Entry

Quality Systems (ISO 13485)

Labelling Requirements

Post-Market Compliance & Surveillance

Choosing a Regulatory Consultant

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