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Lifecycle of a Medical Device

Overview​

Bringing a medical device to the Australian market is not a single event — it is an ongoing regulatory relationship. Compliance begins before the device is designed and continues for as long as it is supplied. This page maps the full regulatory lifecycle so you can understand where any specific requirement sits within the bigger picture, and navigate to the relevant sections of this site.

Stage 1 — Determine if Your Product is a Medical Device​

Before anything else, you need to confirm that your product meets the legal definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989. This depends on the intended purpose — what the manufacturer states or implies the product is for.

If your product is a medical device, it will generally need to be included in the ARTG before it can be supplied in Australia, unless a specific exemption applies.

👉 What is a Medical Device? 👉 TGA Decision Tool — Is my product a medical device?

Stage 2 — Determine the Device Class​

Medical devices in Australia are classified based on risk — the level of invasiveness, duration of use, and potential for patient harm. The higher the class, the more regulatory oversight required.

ClassRisk levelExamples
Class ILowBandages, examination gloves, non-sterile instruments
Class IIaLow-mediumSurgical instruments, contact lenses
Class IIbMedium-highVentilators, orthopaedic implants
Class IIIHighHeart valves, drug-eluting stents
AIMDHigh (active implantable)Pacemakers, cochlear implants
IVD Class 1LowGeneral laboratory instruments
IVD Class 2MediumBlood glucose monitors, pregnancy tests
IVD Class 3Medium-highHIV self-tests
IVD Class 4HighBlood group typing, infectious disease screening for blood supply

Classification must be determined by the manufacturer before any application is made. Using the wrong class is a common and costly mistake — the TGA does not refund application fees for incorrectly classified submissions.

👉 How Classification Works

Stage 3 — Meet the Essential Principles​

The Essential Principles are the fundamental safety and performance requirements every medical device must meet, set out in Schedule 1 of the MD Regulations. There are 6 general principles that apply to all devices, and a further 9 that apply on a case-by-case basis depending on the nature of the device.

Meeting the Essential Principles is the manufacturer's responsibility. Evidence of compliance must be compiled and held before the device is supplied. There is no single mandated format — most manufacturers use a technical file or design dossier.

👉 Essential Principles Overview

Stage 4 — Apply Conformity Assessment Procedures​

Conformity assessment is the process by which a manufacturer systematically examines and documents that their device complies with the Essential Principles. The type of conformity assessment required depends on the device class.

For Class I devices, a manufacturer's Declaration of Conformity is generally sufficient. For higher-class devices, a certified Quality Management System (ISO 13485 or equivalent) and — for the highest-risk classes — a TGA-issued Conformity Assessment Certificate or equivalent from a comparable overseas regulator, are required.

👉 Conformity Assessment Overview

Stage 5 — Obtain and Submit Manufacturer Evidence​

Before a sponsor can apply to include a device in the ARTG (for most device classes above Class I), the TGA must first accept the manufacturer's conformity assessment evidence. This is submitted separately from the ARTG application and must be accepted before the application can proceed.

For Class I devices and Class 1 IVDs, manufacturer evidence is submitted with the ARTG application rather than separately.

Stage 6 — Apply for ARTG Inclusion​

The Australian sponsor submits the application to include the device in the ARTG via the TGA's eBusiness Services (eBS) portal. The application must include the correct device class, the manufacturer's evidence reference, and accurate product information. Once accepted, the TGA issues an ARTG entry number — this is the authorisation to supply the device in Australia.

The level of pre-market review varies significantly by device class. Class I devices may be included with minimal TGA review. Class III and AIMD devices undergo full technical assessment.

👉 ARTG Inclusion Overview

Stage 7 — Supply the Device in Australia​

Once included in the ARTG, the device can be legally imported, supplied, and exported from Australia. The sponsor must ensure:

  • The device continues to be supplied with correct labelling
  • Advertising complies with the Therapeutic Goods Advertising Code
  • The ARTG entry is kept current (including notifying TGA of any variations)
  • Annual charges are paid

Stage 8 — Post-Market Obligations (Ongoing)​

Regulatory obligations do not end at ARTG inclusion. Both the manufacturer and sponsor have ongoing responsibilities for as long as the device is supplied in Australia:

Manufacturers must:

  • Monitor device performance in the field
  • Investigate adverse events and complaints
  • Maintain and update technical documentation
  • Notify sponsors of any changes, safety issues, or regulatory actions

Sponsors must:

  • Report adverse events to the TGA via IRIS within required timeframes
  • Maintain distribution records
  • Manage recalls and field safety corrective actions
  • Ensure manufacturer evidence remains current
  • Pay annual ARTG charges

👉 Post-Market Overview 👉 Adverse Event Reporting

Official Sources​