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Class I, IIa, IIb, III & AIMD

Class I — Low Risk​

Risk level: Low
Schedule 2 rules: Part 1, Rules 1.1–1.4 (general), with specific sub-categories Is and Im

Class I devices are generally non-invasive or minimally invasive, do not sustain or support life, and present low potential for harm when used as intended.

Examples: Bandages, examination gloves, walking frames, non-sterile dressings, tongue depressors, wheelchairs, reading glasses (non-corrective), hospital beds, stethoscopes, non-measuring thermometers.

Key regulatory requirements:

  • Manufacturer applies a Declaration of Conformity only (self-certification)
  • No TGA conformity assessment certificate required
  • Sponsor submits ARTG inclusion application — low TGA review burden
  • Annual charges apply after inclusion

Sub-categories requiring higher conformity assessment:

Sub-classDescriptionAdditional requirement
Class IsClass I supplied sterileQMS certified for sterilisation process
Class ImClass I with measuring functionQMS certified for metrological functions

Class IIa — Low to Medium Risk​

Risk level: Low–Medium
Schedule 2 rules: Part 1, Rules 2.1–2.4 and related active device rules

Class IIa devices are typically invasive for short-term use (less than 30 days), or non-invasive devices used in specific higher-risk applications such as those involving blood or body fluids.

Examples: Surgical instruments (reusable), contact lenses (short-term), blood bags, hearing aids, dental filling materials, catheters for short-term urological use, most diagnostic ultrasound equipment.

Key regulatory requirements:

  • Certified QMS (ISO 13485 or equivalent) required
  • Declaration of Conformity
  • Conformity assessment certificate from a comparable overseas regulator or TGA
  • Sponsor submits ARTG inclusion application
  • Application may be selected for audit

Class IIb — Medium to High Risk​

Risk level: Medium–High
Schedule 2 rules: Part 1, Rules 2.3–3.4 and active device rules

Class IIb devices are typically surgically invasive for long-term use (more than 30 days), active therapeutic devices with potentially hazardous energy delivery, or devices with significant potential for serious harm.

Examples: Ventilators, infusion pumps, orthopaedic implants (non-CNS/cardiovascular), surgical lasers, blood warmers, long-term urological catheters, hip and knee implants, breast implants, spinal implants (not in contact with CNS).

Key regulatory requirements:

  • Full QMS certification required
  • Declaration of Conformity
  • Product-specific conformity assessment certificate required (from EU MDR/MDD notified body, TGA, or other accepted comparable regulator)
  • Sponsor submits ARTG inclusion application
  • Higher likelihood of application audit

Class III — High Risk​

Risk level: High
Schedule 2 rules: Part 1, Rules 3.4–3.5 and special rules

Class III devices are the highest risk general medical device category. They include devices intended for long-term implantation in direct contact with the heart, central circulatory system, or central nervous system, and devices that are absorbed by the body.

From 25 November 2021, active implantable medical devices (AIMDs) are reclassified as Class III — these two categories now effectively merge for new applications.

Examples: Heart valves, coronary stents, cochlear implants (newly classified), drug-eluting stents, pacemakers (newly classified), deep brain stimulators, absorbable sutures (certain), neurovascular devices.

Key regulatory requirements:

  • Full QMS certification (ISO 13485) required
  • Product design dossier assessment required
  • EU MDR CE certificate, TGA Conformity Assessment Certificate, or other accepted comparable regulator certificate required
  • Class III applications supported by EU MDD certificates or US 510(k) are subject to mandatory audit
  • Annual reporting obligations (3 years minimum after inclusion)
  • Stricter post-market surveillance requirements

AIMD — Active Implantable Medical Devices​

Risk level: High
Status: Being phased into Class III

The AIMD classification was the highest risk class for active implantable devices such as pacemakers, cochlear implants, and implantable cardioverter defibrillators. Under regulatory changes that took effect from 25 November 2021, all newly classified active implantable devices are classified as Class III rather than AIMD.

Transitional arrangements:

  • Devices included in the ARTG as AIMD before 25 November 2021 retained their AIMD classification initially
  • Sponsors were required to notify the TGA and submit Class III applications by 1 November 2024
  • Devices not reclassified by that date must cease supply
  • New applications for devices that would previously have been AIMD are now submitted as Class III

If you have an existing AIMD ARTG entry, check the current status of your reclassification obligations.

👉 Reclassifying AIMDs — TGA guidance

Summary Comparison​

Class IClass IIaClass IIbClass III
QMS requiredNo (Is/Im: partial)YesYesYes
Product certificateNoYesYesYes
Mandatory auditNoNoNoSome
Annual reportingNoNoSomeYes
Post-market surveillanceBasicModerateSignificantExtensive

Official Sources​

The complete AIMD section should read:

AIMD — Active Implantable Medical Devices ​ Risk level: High Status: Being phased into Class III Effective date: From 25 November 2021, all new AIMD applications are classified as Class III Examples: Pacemakers, implantable cardioverter-defibrillators (ICDs), cochlear implants, deep brain stimulators, neurostimulators. Key regulatory requirements: Full QMS certification (ISO 13485) required Product design dossier assessment required EU MDR CE certificate, TGA Conformity Assessment Certificate, or other accepted comparable regulator certificate required Mandatory audit applies for most new applications Annual reporting obligations (minimum 3 years after inclusion) Note: Existing AIMD entries retain AIMD classification. All new active implantable devices must be classified as Class III under the updated rules.