Australia – Time, Cost, and Complexity of Registration

Device classification in Australia Class I

Non-sterile; Non-measuring

 Class I

Sterile or Measuring

 Class IIa Class IIb Class III
How long you should expect to wait after submission until approval is granted 2 to 5 business days up to 10 business days between 2 and 6 months 3 to 9 months 6 to 12 months
Validity period for device registrations/ARTG listing The Australian Register of Therapeutic Goods (ARTG) listing does not have a formal expiry date. The registration remains valid indefinitely as long as the annual maintenance fee is paid and all regulatory requirements are met. The Australian Register of Therapeutic Goods (ARTG) listing does not have a formal expiry date. The registration remains valid indefinitely as long as the annual maintenance fee is paid and all regulatory requirements are met. The Australian Register of Therapeutic Goods (ARTG) listing does not have a formal expiry date. The registration remains valid indefinitely as long as the annual maintenance fee is paid and all regulatory requirements are met, meaning it remains active indefinitely provided annual maintenance fees are paid. However, the approval relies on valid supporting conformity assessment evidence (such as CE certificates or MDSAP), which typically expire after 5 years. The Australian Register of Therapeutic Goods (ARTG) listing does not have a formal expiry date. The registration remains valid indefinitely as long as the annual maintenance fee is paid and all regulatory requirements are met, meaning it remains active indefinitely provided annual maintenance fees are paid. However, the approval relies on valid supporting conformity assessment evidence (such as CE certificates or MDSAP), which typically expire after 5 years. The Australian Register of Therapeutic Goods (ARTG) listing does not have a formal expiry date. The registration remains valid indefinitely as long as the annual maintenance fee is paid and all regulatory requirements are met, meaning it remains active indefinitely provided annual maintenance fees are paid. However, the approval relies on valid supporting conformity assessment evidence (such as CE certificates or MDSAP), which typically expire after 5 years.
Registration renewal should be started this far in advance  Start the administrative process (ensuring compliance and payment) at least 1 month before June 30 to avoid issues. It is recommended to begin the renewal preparation process a month or more in advance of the July 1st deadline Renewal of a Class 2a medical device in Australia should be started at least 3 to 6 months before the 30 June expiry date (i.e., by March or earlier). The annual renewal (retention) of the ARTG listing must be completed by 1 July each year to avoid cancellation. Sponsors should begin the renewal process, including paying fees and submitting declarations, at least 4-6 weeks in advance Renewal processes like certificate updates or audits require starting preparations at least 3 to 6 months in advance
Complexity of the registration process for this classification Low Low Low-Moderate Moderate-High High
Overall cost of gaining regulatory approval Low Low Low-Moderate Moderate High

Determine device classification

Classify your device according to the risk-based rules in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. Devices are classified as Class I, Is (Sterile), Im (Measuring), IIa, IIb, or III based on intended purpose and risk.

Step 1 (all classes) – Appoint an Australian Sponsor

If the manufacturer is not based in Australia, a local Australian Sponsor must be appointed.
The sponsor:

  • Submits applications to TGA
  • Acts as the regulatory liaison
  • Must be listed on device labelling

Step 2 (all classes) – Prepare Technical Documentation

  • Technical File or Design Dossier
  • Evidence of conformity to Essential Principles
  • Australian Declaration of Conformity

Step 3 (all classes, varies by pathway) – Provide Manufacturer Evidence

Sponsor submits Manufacturer’s Evidence (e.g., CE certificate or other conformity assessment evidence) via TGA systems for review and acceptance.

Step 4 (all classes) – Submit Medical Device Application (ARTG)

Sponsor submits an application to include the device in the Australian Register of Therapeutic Goods (ARTG). Application includes:

  • Intended purpose
  • Classification
  • GMDN code
  • Manufacturer evidence
  • QMS certificates (Class IIb-Class III)
  • Clinical Evaluation Report (CER) (Class IIb-Class III)
  • Risk Management File (Class IIb-Class III)
  • Applicable fees

Step 5 (Class IIa–III primarily) – TGA Conformity Assessment / Application Audit

TGA may conduct an application audit depending on:

  • Device class
  • Risk profile
  • Type of evidence submitted
  • Conformity assessment can vary (abridged path or full assessment)

Step 6 (all classes) – TGA Decision

  • If approved → Device is included in ARTG
  • If rejected → deficiencies must be addressed

Sponsor receives ARTG inclusion number

Final Step – Market Authorization & Ongoing Compliance

Manufacturer must maintain:

    • Ongoing compliance with Essential Principles
    • Valid conformity assessment evidence
    • Post-market obligations

One MDSAP Audit. Australia Included. If you’re already pursuing Health Canada or FDA compliance, Australia is within reach MDSAP satisfies TGA’s QMS requirements too. Qaralogic builds your compliance infrastructure to unlock multiple markets without duplicating the work.

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