Australia Medical Device Grouping Requirements: TGA Kind-of-Device and ARTG Rules

Quick answer

What are Australia medical device grouping requirements?

Under the Therapeutic Goods Administration (TGA), ARTG inclusion applications are made for a "kind of medical device"—not for each individual stock-keeping unit (SKU). Devices belong to the same kind when they share the same sponsor, manufacturer, classification, and Global Medical Device Nomenclature (GMDN) code. For Class III, active implantable medical devices (AIMD), and most Class 4 IVDs, TGA also requires the same unique product identifier (UPI)—creating a narrower grouping than for lower-risk classes. Lower-risk devices may be grouped more broadly: multiple models or brands can sit under one ARTG entry when the four core criteria align, as TGA illustrates with IV infusion sets. Class III and AIMD may include variants—design variations for patient anatomical requirements with the same intended purpose—where the variant type is on TGA's allowable list; other variant types need a written submission to devices@tga.gov.au. Determine your kind before lodging via TGA Business Services (TBS). This guide summarises official TGA grouping rules for education; confirm current requirements on tga.gov.au before filing.

Who this applies to

This guide is for regulatory affairs teams, Australian sponsors, and manufacturers preparing Australia medical device grouping decisions before ARTG inclusion.

Roles and scenarios:

Product scope: Medical devices and in vitro diagnostic medical devices (IVDs) seeking supply in Australia under TGA regulation. Grouping applies across risk classes, but Class III, AIMD, and Class 4 IVD entries are narrower because of the UPI requirement.

Who is outside immediate scope: Products not regulated as medical devices or IVDs under TGA rules follow different pathways. This article addresses kind-of-device grouping for ARTG inclusion only—not classification methodology, GMDN selection detail, or post-market obligations (see related articles in Official sources).

What is a "kind of medical device"?

In Australia's regulatory framework, the Australian Register of Therapeutic Goods (ARTG) records market authorisation by kind of medical device, not by every individual catalogue number. TGA's inclusion process is designed so one application can cover multiple models, sizes, or configurations that meet the same-kind criteria.

The concept serves two practical purposes:

1. Administrative efficiency — Sponsors avoid duplicating evidence packages for every minor model variation that shares the same regulatory identity.
2. Risk-proportionate granularity — Higher-risk devices require tighter grouping (including UPI alignment), while lower-risk devices permit broader kind definitions.

When you prepare an ARTG inclusion application through TGA Business Services (TBS), you define the kind your evidence supports. Listing every model you intend to supply under that kind is essential; devices outside the defined kind require a separate ARTG entry.

Same-kind criteria by risk class

TGA's core same-kind test applies four criteria to all medical devices and IVDs. High-risk classes add a fifth criterion.

Core criteria (all classes)

These four elements define the baseline kind of medical device for ARTG purposes. If any criterion differs between products you wish to supply, TGA expects separate ARTG entries unless a specific variant rule applies (see Variants for Class III and AIMD).

Additional criterion for high-risk devices

TGA's overview contrasts high-risk narrow kind definitions with lower-risk broader kind definitions. A practical lower-risk example: multiple IV infusion set models from the same manufacturer and sponsor sharing one GMDN code may group under a single ARTG entry.

IVD grouping differences

IVDs are regulated under the same kind-of-device framework as general medical devices. The same four core criteria—sponsor, manufacturer, classification, and GMDN—determine whether IVD products belong to one kind.

Class 4 IVD products generally require the same UPI in addition to the four core criteria, aligning IVD high-risk grouping with Class III and AIMD narrow-kind rules. TGA notes an exception for immunohaematology reagents, where the UPI requirement does not apply in the same manner as for other Class 4 IVD categories.

For Class 2 IVD and Class 3 IVD products, grouping follows the broader pattern: same sponsor, manufacturer, classification, and GMDN can encompass multiple models without a UPI constraint. Sponsors should still confirm that intended-use statements, analyte targets, and specimen types align with the kind definition TGA will accept—classification and GMDN selection must reflect the full product scope of the grouped entry.

Variants for Class III and AIMD

Variants allow certain design differences within a Class III or AIMD ARTG kind without requiring a wholly separate entry. Under the Therapeutic Goods Regulations, section 41BE, a variant is a device whose design is varied to meet patient anatomical requirements while retaining the same intended purpose as the primary device in the kind.

TGA maintains an allowable variant types list for ARTG inclusion. When your proposed variant type appears on that list, you may include it within the kind subject to standard inclusion requirements and appropriate labelling.

If the variant type is not on the allowable list, you must make a written submission to TGA before proceeding. Contact devices@tga.gov.au and include supporting information on labelling, instructions for use (IFU), and advertising where relevant. Do not assume unlisted variant types can be added to an existing ARTG entry without TGA approval.

Variant rules apply specifically to Class III and AIMD contexts in TGA's grouping guidance. Lower-risk classes achieve broader grouping through the core four criteria rather than through the formal variant mechanism.

Step-by-step: determine your ARTG kind before inclusion

Follow this workflow when planning Australia medical device grouping ahead of an ARTG inclusion application.

Step 1: Confirm TGA classification for each product

Assign the correct TGA risk classification to every model you intend to supply. Classification drives whether UPI alignment is required and how narrow your kind definition must be. If two products carry different classifications, they cannot share one ARTG kind regardless of GMDN overlap.

Step 2: Select and validate GMDN terms

Identify the GMDN code that accurately describes the device kind. All products grouped under one ARTG entry must share the same GMDN term. Review TGA's GMDN guidance if multiple nomenclature options appear to fit—choosing an overly broad GMDN to force grouping creates compliance risk at audit.

Step 3: Map sponsor and manufacturer identities

Confirm the Australian sponsor and manufacturer for each product variant. A change in either entity—even when classification and GMDN match—creates a separate kind requiring its own ARTG application.

Step 4: Apply the UPI test for high-risk devices

For Class III, AIMD, and applicable Class 4 IVD products, verify that every model in the proposed kind shares the same UPI. If UPIs differ, plan separate ARTG entries or restructure the product line before application.

Step 5: Assess variant eligibility (Class III / AIMD only)

If design variations exist for anatomical fit with the same intended purpose, check whether each variation qualifies as an allowable variant type. For unlisted variant types, prepare a written submission to devices@tga.gov.au and await TGA direction before including those variants in the kind.

Step 6: Decide one ARTG entry vs separate entries

Compare the product portfolio against the criteria table in this guide. Document which models, brands, and configurations fit one kind and which require separate entries. Build a kind matrix for internal sign-off before TBS data entry.

Step 7: Lodge the inclusion application via TBS

Submit your ARTG inclusion application through TGA Business Services, defining the kind scope your evidence supports. The TGA medical device inclusion process covers application steps beyond grouping; ensure your dossier addresses the full kind—not individual SKUs in isolation.

Step 8: Maintain kind integrity post-inclusion

After ARTG listing, new models that meet all same-kind criteria may be added within the existing entry subject to TGA change-notification rules. Models that fail any criterion require a new ARTG application.

Comparison: one ARTG entry vs separate entries

Checklist

Use this checklist alongside TGA's official What kind of medical device is it page before lodging via TBS.

Core grouping criteria

• Sponsor confirmed identical for all models in the proposed kind
• Manufacturer confirmed identical for all models in the proposed kind
• TGA classification confirmed identical for all models in the proposed kind
• GMDN code selected and validated as shared across all grouped products

High-risk additional checks

• UPI verified identical for Class III, AIMD, or applicable Class 4 IVD products
• Class 4 IVD immunohaematology reagent exception reviewed if applicable

Variant assessment (Class III / AIMD)

• Each design variation assessed against section 41BE variant definition
• Variant type checked against TGA allowable variant types list
• Written submission to devices@tga.gov.au prepared for any unlisted variant type
• Labelling, IFU, and advertising implications documented for variants

Application readiness

• Kind matrix documented showing which models fit one entry vs separate entries
• ARTG inclusion application prepared for the defined kind via TBS
• Current TGA pages on tga.gov.au reviewed for updates before submission

Common pitfalls

Applying per-SKU instead of per kind. TGA ARTG applications cover a kind of medical device, not each catalogue line. Filing separate applications for models that meet all same-kind criteria wastes resources and can create inconsistent ARTG records.

Assuming brand name differences always require separate entries. Lower-risk devices with different brand names but the same sponsor, manufacturer, classification, and GMDN may group under one kind. Do not split entries based on branding alone.

Overlooking the UPI requirement for high-risk devices. Class III, AIMD, and most Class 4 IVDs need the same UPI within a kind. Grouping multiple UPIs under one ARTG entry violates TGA's narrow-kind rule.

Using an overly broad GMDN to force grouping. Selecting a GMDN term that does not accurately describe every product in the kind exposes the sponsor to inclusion deficiencies and post-market compliance queries.

Adding unapproved variant types without written TGA submission. Variant types not on TGA's allowable list require a written submission to devices@tga.gov.au with labelling, IFU, and advertising details. Including unapproved variants in an ARTG kind creates regulatory non-compliance.

Treating IVDs under a different grouping framework. IVDs follow the same kind-of-device rules as general medical devices, with Class 4 IVD UPI requirements as the primary difference. Do not apply ad hoc grouping logic outside TGA's published criteria.

Ignoring manufacturer changes across contract sites. If the legal manufacturer differs between otherwise similar products—even when the same corporate group owns both sites—the kind criteria are not met.

Failing to re-check kind scope when adding post-approval models. New models added after ARTG inclusion must still satisfy all same-kind criteria. A model that fails any criterion needs a new ARTG entry, not an informal extension.

FAQ

What is a "kind of medical device" in Australia?

A kind of medical device is the unit of ARTG inclusion under TGA rules. Instead of registering each SKU separately, sponsors apply for a kind defined by shared sponsor, manufacturer, classification, and GMDN criteria—and, for high-risk devices, the same UPI. One ARTG entry can cover multiple models that meet these criteria.

Can I group multiple models under one ARTG entry?

Yes, when all same-kind criteria align. Lower-risk classes allow broader grouping—for example, multiple IV infusion set models from the same manufacturer and sponsor under one GMDN. Class III, AIMD, and most Class 4 IVDs require the same UPI, which narrows how many models can share one entry.

What is the difference between grouping for Class I vs Class III devices?

Class I (and other lower-risk classes) group under the four core criteria—sponsor, manufacturer, classification, and GMDN—without a UPI constraint, permitting broader kinds with multiple models or brands. Class III devices additionally require the same UPI, producing a narrower kind. Class III may also use the variant mechanism for anatomical design differences with the same intended purpose.

Do IVDs follow the same kind-of-device rules?

Yes. IVDs use the same kind-of-device framework as general medical devices. The key difference is that Class 4 IVDs (except immunohaematology reagents in the manner TGA describes) generally require the same UPI alongside the four core criteria, similar to Class III and AIMD grouping.

What are acceptable variants for TGA ARTG inclusion?

Under section 41BE, a variant varies device design for patient anatomical requirements while keeping the same intended purpose. TGA publishes allowable variant types for Class III and AIMD kinds. Variant types not on the list require a written submission to devices@tga.gov.au with supporting labelling, IFU, and advertising information.

When do I need a unique product identifier (UPI)?

A UPI is required as an additional same-kind criterion for Class III general medical devices, AIMD, and most Class 4 IVDs. All products grouped under one ARTG kind in these categories must share the same UPI. Lower-risk classes and most non–Class 4 IVD categories do not impose this additional constraint.

Official sources

• TGA — What kind of medical device is it (same sponsor, manufacturer, classification, GMDN; UPI for Class III/AIMD/Class 4 IVD; variant rules): https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/what-kind-medical-device-it
• TGA — Overview of medical devices and IVD regulation (high-risk narrow kind vs lower-risk broader kind; IV infusion set example): https://www.tga.gov.au/products/medical-devices/overview/overview-medical-devices-and-ivd-regulation
• TGA — Medical device inclusion process (applications for a kind, not each SKU; TGA Business Services): https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process
• TGA Business Services (TBS) / EBS variant help (section 41BE variant definition): TGA Enterprise Business Services variant guidance at https://www.tga.gov.au
• TGA devices contact for unlisted variant types: devices@tga.gov.au

TGA guidance may be updated without notice. Verify current grouping requirements on tga.gov.au before lodging an ARTG inclusion application.