If you want to import or supply an in vitro diagnostic (IVD) medical device in Australia, you need to know how the Therapeutic Goods Administration (TGA) treats it. The TGA says that, unless exempt or excluded, IVDs must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia (TGA: In vitro diagnostic devices).
This guide covers what counts as an IVD, how the four IVD risk classes work, how an Australian sponsor applies for ARTG inclusion, what Manufacturer Evidence the TGA accepts, when applications are audited, and how in-house IVDs fit in. If your product is not an IVD, see our general guide to medical device classification in Australia instead.
What counts as an IVD in Australia?
The TGA describes an IVD as a medical device that is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro to examine specimens derived from the human body, solely or principally to give information about a physiological or pathological state or a congenital abnormality, to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures (TGA: IVD medical devices definitions and links). The legal definition sits in the Therapeutic Goods (Medical Devices) Regulations 2002.
Two points from that definition matter in practice:
- Intended purpose drives everything. What the manufacturer says the product is for (in the labelling, instructions for use and advertising) decides whether it is an IVD and which class it falls into.
- General laboratory products are not automatically IVDs. The TGA says the definition does not cover products for general laboratory use that are not manufactured, sold or presented specifically for use as an IVD.
The TGA gives pregnancy tests, COVID rapid antigen tests and pathology tests that check a person's iron levels as examples of IVDs. IVDs may be used by health professionals in laboratories or at the point of care, and some are approved for self-testing by the general public (TGA: In vitro diagnostic devices).
For the wider product range we support, see our medical devices services page.
IVD classification: Classes 1 to 4 (Schedule 2A)
IVDs have their own classification system, separate from the Class I to III rules for other medical devices. The rules are in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002 (AustLII: Schedule 2A). IVDs are classified by the health risk, to the public or to an individual, that could arise from an incorrect result. The higher that risk, the higher the class and the more assessment and monitoring is required (TGA: Classifying IVDs for supply in Australia).
| IVD class | Level of risk (TGA) | TGA examples |
|---|---|---|
| Class 1 | No public health risk or low personal risk | Sample collection container; microbiological culture media |
| Class 2 | Low public health risk or moderate personal risk | Pregnancy and fertility self-testing kits; cholesterol test |
| Class 3 | Moderate public health risk or high personal risk | Tests to detect a sexually transmitted disease (for example, chlamydia, gonorrhoea); human genetic tests |
| Class 4 | High public health risk | Blood donor screening tests for HIV; test for Ebola |
Source: TGA: Overview of medical devices and IVD regulation and TGA: Classifying IVDs.
Key classification rules
- Rule 1.1 (Class 4): IVDs that detect transmissible agents in blood, blood components, cells, tissues or organs to assess their suitability for transfusion or transplantation, or that detect a transmissible agent causing a serious disease with a high risk of spreading in Australia.
- Rule 1.3 (Class 3): includes IVDs for sexually transmitted agents, cancer diagnosis or staging, companion diagnostics, human genetic testing, prenatal screening and some other high personal-risk uses.
- Rule 1.4 (self-testing): an IVD for self-testing is Class 3 unless the result does not determine a serious condition, or the test is preliminary and follow-up testing is required.
- Rule 1.6 (Class 1): instruments, specimen receptacles (other than those for self-testing) and microbiological culture media.
- Rule 1.7 (Class 2): IVDs not captured by any other rule.
Some points to keep in mind:
- The manufacturer classifies the device using Schedule 2A and its intended purpose.
- The highest rule wins. If more than one rule applies, the highest class applies. Identical devices can be classified differently if they have a different diagnostic purpose (TGA: Classifying IVDs).
- Get it right before you apply. The sponsor must enter the correct class in the ARTG application, and the TGA says it cannot refund application fees for applications entered with the wrong class (TGA: Classification of medical devices).
Our medical device classification guide covers the non-IVD rules in detail. This post does not repeat them.
ARTG inclusion pathway for sponsors
Only an Australian sponsor can apply to include an IVD in the ARTG. A sponsor can apply if the device complies with the Essential Principles and an appropriate conformity assessment procedure has been applied (TGA: Including IVDs in the ARTG). Applications are made through the TGA Business Services portal (TGA: Application and market authorisation for IVDs).
What changes by class
| Class | What the TGA requires (summary) |
|---|---|
| Class 1 | No Manufacturer Evidence is required. The manufacturer must still apply the conformity assessment procedure and prepare an Australian Declaration of Conformity, and the sponsor must provide evidence of conformity on request. |
| Class 2 | Manufacturer Evidence must be submitted and accepted by the TGA before the ARTG application is lodged. |
| Class 3 | Manufacturer Evidence accepted first, plus an Australian Declaration of Conformity with the application. |
| Class 4 | Manufacturer Evidence accepted first, plus a TGA-issued Design Examination or Type Examination certificate, as appropriate. |
Source: TGA: Including IVDs in the ARTG.
Basic steps
- Confirm the product is an IVD and settle its intended purpose with the manufacturer.
- Classify it under Schedule 2A.
- For Class 2, 3 or 4, submit Manufacturer Evidence through TGA Business Services and wait for it to be accepted.
- Lodge the ARTG inclusion application, pay the application fee and attach the class-specific documents.
- Respond to any application audit.
- Once included, meet the ongoing obligations of an ARTG sponsor.
The TGA also lists ways to supply devices that are not in the ARTG, such as clinical trials, the Special Access Scheme and Authorised Prescribers (TGA: Including IVDs in the ARTG). For the wider device process, see our guide to TGA medical device approval regulations and process.
Manufacturer Evidence and overseas approvals
Manufacturer Evidence is the conformity assessment document that shows the manufacturer's quality management system (and, where relevant, product review) meets requirements. The sponsor submits it through TGA Business Services and receives a Manufacturer Evidence identifier, which is needed for every IVD application except Class 1 IVDs. The TGA says there is no fee for a Manufacturer Evidence application (TGA: Manufacturer Evidence for medical devices).
For IVDs, the TGA lists these types of evidence with ongoing acceptance (TGA: Transitioning to new manufacturer evidence for IVDs):
- TGA Conformity Assessment certificate
- Certificate issued under the EU In Vitro Diagnostic Regulation (IVDR)
- Medical Device Single Audit Program (MDSAP) certificate, for Class 2 and 3 IVDs
- MDSAP certificate with acceptable product review evidence: a Health Canada medical device licence, US Food and Drug Administration (FDA) premarket approval (PMA), Singapore Health Sciences Authority (HSA) approval, or Japan Pharmaceuticals and Medical Devices Agency (PMDA) premarket approval
The overseas documents must be for the same device: the same design, intended purpose and user, and the same indications (TGA: Use of market authorisation evidence from comparable overseas regulators).
Cut-off dates for older EU evidence
| Evidence type | TGA cut-off date |
|---|---|
| Certificate issued under the EU In Vitro Diagnostic Directive (IVDD) | Class 4 IVD: until 31 December 2027 |
| ISO 13485 certificate with an EU Declaration of Conformity under the IVDD (made before 26 May 2022) | Class 3 IVD: until 26 May 2026 (this route has now ended) |
| ISO 13485 certificate on its own | Not accepted after 26 May 2023 |
Source: TGA: Transitioning to new manufacturer evidence for IVDs. For IVDD certificates, the sponsor may also need to show that the manufacturer meets the EU IVDR extension eligibility conditions.
For a fuller comparison of CE marking, FDA and MDSAP evidence, see our guide to using CE, FDA and MDSAP evidence for TGA approval.
Application audits
Any device application may be selected for audit. The TGA must select some applications for a mandatory audit with assessment fees, under regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (TGA: Understanding application audit rules). For IVDs, these include:
- Class 3 and Class 4 IVDs supported by MDSAP certification, including those with US FDA 510(k) clearance
- IVDs intended for self-testing or point-of-care testing
The TGA can also select other applications for a non-mandatory audit, without assessment fees. An audit can review conformity assessment evidence, device technical files and other evidence that the device meets regulatory requirements. The depth of assessment depends on the IVD's risk class and the conformity assessment evidence supporting it (TGA: Application and market authorisation for IVDs).
The TGA's MDSAP frequently asked questions note that Class 2 or 3 IVD applications with MDSAP certification are acceptable with or without FDA 510(k) clearance, but those without comparable overseas product approval are more likely to be selected for audit.
Fees
Application fees apply to ARTG inclusion, and audit assessment fees apply when an application is selected for a mandatory audit (TGA: Application and market authorisation for IVDs). The amounts depend on the class and the type of evidence, and the TGA updates them each financial year. For the current government fee schedule and how the fees fit together, see our guide on how much TGA approval costs. For consultancy support, contact us for a quote.
In-house IVDs
In-house IVDs are made and used by an Australian laboratory or laboratory network and are not supplied outside it. They follow different rules (TGA: Manufacturing or supplying in-house IVDs):
- Class 1 to 3 in-house IVDs are entered on a separate in-house IVD database, not the ARTG (TGA: Including IVDs in the ARTG).
- Class 4 in-house IVDs must be included in the ARTG. Laboratories can either obtain TGA conformity assessment certificates (a quality management system certificate and a design examination certificate) first, or apply directly using their existing National Association of Testing Authorities (NATA) accreditation to ISO 15189, together with compliance with the National Pathology Accreditation Advisory Council (NPAAC) in-house IVD standard, or a relevant TGA manufacturing licence.
- Mandatory audit: Class 4 in-house IVD applications are subject to a mandatory application audit of the analytical and clinical evidence.
If you are a laboratory developing your own tests, read the TGA guidance in full because the rules are specific to this group.
Quick checklist for IVD sponsors
- Is the product an IVD under the TGA definition, based on the manufacturer's intended purpose?
- Which Schedule 2A class applies, using the highest applicable rule?
- Is there an Australian sponsor to make the application?
- For Class 2 to 4: is acceptable Manufacturer Evidence in place, and are any EU IVDD-based documents still within the TGA cut-off dates?
- For Class 3 or 4: is the Australian Declaration of Conformity or the TGA Design or Type Examination certificate ready?
- Is the application likely to face a mandatory audit (MDSAP-supported Class 3 or 4, or self-testing or point-of-care)?
- Have you budgeted for application and any audit assessment fees?
Talk to R2 Pharma Solutions
Not sure which class your test falls into, or whether your overseas certificates will be accepted? R2 Pharma Solutions can review your IVD's intended purpose and evidence before you lodge. Find out more about our medical device and IVD services or contact us for a quote.
This post is general information, not legal or regulatory advice. Always confirm the current rules with the TGA before you apply.