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How Classification Works

Overview​

Australia uses a risk-based classification system for medical devices. The higher the potential risk a device poses to patients and users, the higher its classification and the more regulatory scrutiny it receives. Classification determines which conformity assessment procedures apply, what manufacturer evidence is required for ARTG inclusion, whether an application audit is likely, and what ongoing post-market obligations apply. Getting the classification right before applying for ARTG inclusion is critical — the TGA does not refund application fees for incorrectly classified submissions.

The Classification Framework​

The classification rules are set out in Schedule 2 (general medical devices) and Schedule 2A (IVD medical devices) of the Therapeutic Goods (Medical Devices) Regulations 2002. The rules are applied by the manufacturer — not the TGA. The TGA may challenge or override a manufacturer's classification during an application audit, but the initial determination is the manufacturer's responsibility.

General Medical Device Classes​

ClassRisk LevelOverview
Class ILowNon-invasive or minimally invasive, no life-sustaining function
Class IIaLow–MediumShort-term invasive use, or specific non-invasive higher-risk applications
Class IIbMedium–HighLong-term invasive use, active therapeutic devices, high energy delivery
Class IIIHighContact with central nervous system, heart, or central circulatory system; long-term implants
AIMD*HighActive implantable devices — being phased into Class III

Note: The AIMD class is being reclassified into Class III. Devices submitted as AIMD before 25 November 2021 retain that classification; all new active implantable devices are classified as Class III.

IVD Device Classes​

ClassRisk LevelOverview
Class 1LowGeneral laboratory instruments, reagents for non-listed analytes
Class 2MediumBlood glucose monitors, pregnancy tests, cholesterol tests
Class 3Medium–HighHIV self-tests, PSA tests, companion diagnostics
Class 4HighBlood group typing, infectious disease screening for blood supply

The Four Classification Factors​

For general medical devices, classification rules in Schedule 2 are based on four key factors:

1. Invasiveness How far the device enters the body — non-invasive, invasive through a body orifice, surgically invasive (puncturing skin), or implantable.

2. Duration of use

  • Transient: intended for continuous use for less than 60 minutes
  • Short-term: intended for continuous use between 60 minutes and 30 days
  • Long-term: intended for continuous use for more than 30 days

3. Location in the body Where the device is intended to be used — peripheral, central circulatory system, central nervous system, heart, etc. Contact with higher-risk anatomical locations results in a higher classification.

4. Energy source Whether the device is active (relies on an energy source other than gravity or the human body) or passive. Active devices have specific classification rules under Schedule 2, Part 2.

The "Higher Classification Wins" Principle​

A device may meet the criteria for multiple classification rules. In this case, the highest applicable classification applies. The classification rules in Schedule 2 include a hierarchy — special rules in Part 2 (active devices) and Part 3 (special rules) can override the general rules in Part 1. Manufacturers must work through all applicable rules and apply the highest classification that results.

Intended Purpose Drives Classification​

Like the definition of a medical device itself, classification is determined by intended purpose. The same physical product can attract different classifications depending on what the manufacturer states it is for. A catheter used for short-term drainage is classified differently from one intended for long-term use. A software application that monitors vital signs is classified differently from one that actively provides therapy recommendations.

Manufacturers must ensure the intended purpose stated in labelling, instructions for use, and technical documentation is consistent with the classification applied.

Class I Sub-Categories​

Within Class I there are two important sub-categories that affect conformity assessment requirements:

  • Class Is — Class I device supplied in a sterile state. Requires a certified QMS covering at least the sterilisation process.
  • Class Im — Class I device with a measuring function. Requires a certified QMS covering the aspects of the device related to conformity of the metrological functions.

Class Is and Class Im devices have higher conformity assessment requirements than standard Class I despite sharing the same classification level for ARTG purposes.

How to Determine Your Classification​

  1. Read the classification rules in Schedule 2 (or Schedule 2A for IVDs)
  2. Identify all rules that may apply to your device based on its intended purpose
  3. Apply the higher classification where multiple rules apply
  4. Document your classification rationale in your technical file
  5. Use the TGA's classification guidance documents and decision tools to validate your conclusion

The TGA publishes detailed guidance on classifying both general medical devices and active/software devices:

👉 Classification of medical devices (not IVDs) — TGA guidance (PDF) 👉 Classifying active and software medical devices — TGA guidance 👉 IVD classification guidance — TGA

Official Sources​