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-class | Description | Additional requirement |
|---|---|---|
| Class Is | Class I supplied sterile | QMS certified for sterilisation process |
| Class Im | Class I with measuring function | QMS 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 I | Class IIa | Class IIb | Class III | |
|---|---|---|---|---|
| QMS required | No (Is/Im: partial) | Yes | Yes | Yes |
| Product certificate | No | Yes | Yes | Yes |
| Mandatory audit | No | No | No | Some |
| Annual reporting | No | No | Some | Yes |
| Post-market surveillance | Basic | Moderate | Significant | Extensive |
Official Sources
- Schedule 2 — Classification rules
- Classification guidance (PDF) — TGA, July 2024
- Reclassifying AIMDs — TGA