Determining the Kind of Medical Device for TGA Inclusion – Australian Regulatory Overview

Overview of Device Classification and Inclusion

In Australia, all medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before supply, except for exempt devices. The Therapeutic Goods Administration (TGA) classifies devices into four risk-based classes (I, IIa, IIb, III) according to the level of potential harm and intended use. Correct classification determines conformity assessment procedures, evidence requirements, and whether a device can be considered a variant of an already included device or requires a separate ARTG entry. Source: What kind of medical device is it? - TGA

Key Factors in Determining Device Kind

Intended Purpose

The intended purpose, as stated by the manufacturer, is the primary determinant of classification and whether a device falls within the same kind as an existing ARTG entry. Changes in intended purpose (e.g., new clinical claims) typically require a separate entry.

Design and Technological Differences

Devices are considered the same kind if they have the same intended purpose and do not differ significantly in design, materials, or technology. Minor variations (e.g., size range, colour) may qualify as variants within the same ARTG entry, while substantial changes (e.g., new active ingredient, major material change) usually require separate inclusion.

Risk-Based Classification Rules

Classification follows Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002:

• Class I: Low risk (e.g., non-invasive, reusable surgical instruments)
• Class IIa: Low-medium risk (e.g., invasive short-term, active therapeutic low-risk)
• Class IIb: Medium-high risk (e.g., invasive long-term, active therapeutic medium-risk)
• Class III: High risk (e.g., implantable, active life-supporting)

Variant Rules

A variant is a medical device that:

• Has the same sponsor and manufacturer
• Shares the same intended purpose
• Differs only in aspects permitted under TGA variant guidelines (e.g., dimensions within a range, packaging differences)
• Does not introduce new risks or change the risk classification

Variants can be included under the same ARTG entry, reducing administrative burden.

Process Implications

• Same Kind/Variant: Can be added to existing ARTG entry via amendment (faster, lower cost)
• Different Kind: Requires new ARTG inclusion application with full conformity assessment evidence
• Incorrect classification or variant determination can lead to compliance actions, including cancellation of ARTG entry

Practical Guidance for Manufacturers

• Review the intended purpose wording carefully
• Compare design specifications against existing ARTG entries
• Use TGA classification tools and guidance documents
• Consult TGA if uncertainty exists regarding variant status

This framework ensures risk-proportionate regulation while allowing efficient inclusion of minor product variations. Detailed classification rules, variant examples, and decision trees are provided in the official TGA guidance on determining the kind of medical device. Source: What kind of medical device is it? - TGA

The content reflects TGA requirements as of the latest available guidance and supports manufacturers in achieving compliant market entry in Australia.