Interactive assessment tools

Explore a possible Australian regulatory pathway

Follow one guided sequence to screen your product, estimate its preliminary classification, identify a possible evidence route and download a summary.

Steps 1–2 · Device status and classification

Screen your product, then explore its likely classification

Answer from the manufacturer’s documented intended purpose—not how a customer might choose to use the product.

Product screening

Is it likely to be a medical device?

What is the product’s main intended purpose?How does it achieve its principal intended action?Which description is the closest?

Risk classification

What is the likely Australian classification?

Complete the first questionnaire with a “likely medical device” result to open this tool.

Step 3 · Evidence route

Which evidence pathway can support ARTG inclusion?

Select the Australian class and the strongest regulatory evidence already held by the legal manufacturer.

Manufacturer evidence pathway

Match the device to an available regulatory-evidence route

Which type of medical device is it?What is the Australian classification?What is the strongest evidence held?

All recognised route families

Explore all evidence pathways

Open the full reference catalogue. Availability depends on class, scope, validity, transition dates and product-level evidence.

TGA / Australian requirements

Australian self-declaration

Best suited to: Class I non-sterile, non-measuring devices—including reusable surgical instruments; Class 1 IVD; qualifying procedure packs

Australian Declaration of Conformity. No manufacturer-evidence certificate is normally submitted for the basic Class I / Class 1 IVD pathway. Reprocessing evidence must be maintained for reusable surgical instruments.

TGA-issued CA certificate

TGA Conformity Assessment

Best suited to: Any eligible class where the manufacturer seeks Australian certification or does not hold usable overseas evidence

Part 1 Full QMS, or another applicable Schedule 3 procedure. Design/type examination is added where the device class and procedure require it.

European Union

EU MDR notified-body evidence

Best suited to: Class Is, Im, IIa, IIb and III medical devices, plus eligible EU MDR evidence for reusable surgical instruments

Typically Annex IX Chapter I QMS or Annex XI product-conformity certification, with technical-documentation or type-examination evidence where required.

MDSAP auditing organisation + FDA

MDSAP + US FDA

Best suited to: Commonly Class IIa, IIb, III and relevant IVD pathways

MDSAP certificate for the manufacturer plus the matching 510(k) Summary, De Novo Decision Summary, PMA or evidence of exemption, as applicable.

MDSAP auditing organisation + Health Canada

MDSAP + Health Canada

Best suited to: Commonly Class IIa, IIb, III and IVD pathways

MDSAP certificate plus the matching Canadian medical-device licence for the product and risk class.

Japan

Japan PMDA / MHLW

Best suited to: Commonly Class IIa, IIb, III and relevant IVD pathways

Japanese QMS certificate or MDSAP certificate, paired with the applicable pre-market certificate or pre-market approval.

Singapore

Singapore HSA

Best suited to: Devices entered in the Singapore Register of Health Products

Extract or copy of the Singapore register entry at the corresponding Class B, C or D level, subject to the Australian class and device type.

United Kingdom

UK approved-body evidence

Best suited to: Eligible devices certified under recognised UK arrangements

Relevant approved-body certificate under the UK framework. The exact certificate and product-assessment evidence must match the Australian class.

European Union — IVDs

EU IVDR notified-body evidence

Best suited to: Class 2, 3 and 4 IVD medical devices

Annex IX Chapter I QMS or eligible Annex XI evidence, plus technical-documentation assessment for higher-risk, self-test, near-patient or companion-diagnostic pathways as applicable.

Plain-English glossary of regulatory terms

ARTG: Australian Register of Therapeutic Goods—the register in which a device generally must be included before lawful supply.
QMS: Quality management system—the manufacturer’s controlled system for designing, making and monitoring its devices.
MDSAP: Medical Device Single Audit Program—an audit program accepted by participating regulators. A certificate alone may not provide the required product evidence.
Comparable overseas regulator: An overseas authority or assessment body whose specified evidence the TGA may accept to support an Australian application.
Product assessment: A regulator or conformity-assessment body’s review of the technical documentation, design or type for a particular device or device group.
Australian sponsor: The Australian-based person or company legally responsible for the device’s ARTG inclusion and local supply obligations.

Step 4 · Your report

Get your Pacific Access Medical assessment report

Turn your three tool results into a branded, downloadable summary and choose whether you would like to discuss professional ARTG support.

1Complete assessmentFinish the three decision tools.
2Request reportChoose the Pacific Access Medical report.
3Add your detailsEmail is required; all other details are optional.
4Choose supportOptionally request a consultation.
5Review & downloadReview the notice and save your report.

Need a closer review?

Online tools cannot resolve every regulatory boundary

Borderline products, special classification rules and complex evidence combinations often need a product-specific assessment.

Contact Pacific Access Medical