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Overview & Procedures

Overview​

Conformity assessment is the systematic process by which a manufacturer examines and documents that their medical device complies with the Essential Principles. It is a pre-condition for ARTG inclusion — for most device classes above Class I, the manufacturer's conformity assessment evidence must be accepted by the TGA before an ARTG application can proceed. The conformity assessment procedures are set out in Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002.

Two Pathways to Conformity Assessment Evidence​

There are two main ways a manufacturer can obtain the conformity assessment evidence required for an Australian ARTG application:

Pathway 1 — TGA Conformity Assessment Certification​

The manufacturer applies directly to the TGA for a Conformity Assessment Certificate. The TGA assesses the manufacturer's quality management system (QMS) and, for higher-risk devices, the product design documentation. This pathway results in TGA-issued certificates that are specific to Australian requirements.

👉 TGA Certification

Pathway 2 — Comparable Overseas Regulator Evidence​

The manufacturer uses conformity assessment certificates or approvals from a recognised overseas regulator as the manufacturer evidence for an Australian ARTG application. This is the most common pathway for manufacturers who already hold CE marking, FDA clearance/approval, or other recognised overseas approvals.

👉 Comparable Overseas Regulators

Conformity Assessment Procedures by Device Class​

The required conformity assessment procedures depend on the device class. The table below provides a summary — always refer to Schedule 3 and current TGA guidance for the definitive requirements.

ClassQMS RequiredProduct AssessmentTypical Evidence Type
Class INoNoDeclaration of Conformity only
Class Is / ImPartial (sterilisation / measurement aspects)NoQMS certificate (partial scope) + Declaration
Class IIaYes (full)NoISO 13485 QMS certificate + Declaration
Class IIbYes (full)YesQMS cert + Product design certificate
Class IIIYes (full)Yes (design dossier)Full QMS + Product assessment
IVD Class 1NoNoDeclaration of Conformity only
IVD Class 2YesNoQMS certificate + Declaration
IVD Class 3YesYesQMS cert + Product certificate
IVD Class 4YesYesFull QMS + Product design assessment

Schedule 3 — Conformity Assessment Parts​

Schedule 3 sets out specific conformity assessment procedures called "Parts." Different Parts apply depending on the device class and the manufacturer's chosen pathway:

  • Part 1 — Full Quality Assurance — covers the full QMS including design, production, and post-market. Required for most Class IIb and above.
  • Part 2 — Type Examination — product-specific assessment of device design.
  • Part 3 — Verification — assessment of individual or batch production.
  • Part 4 — Production Quality Assurance — QMS covering production phase only.
  • Part 5 — Product Quality Assurance — QMS covering product verification only. (Note: The TGA is proposing to phase out Part 5 — check current consultation status.)
  • Part 6 — Declaration of Conformity — self-declaration by the manufacturer, applicable to Class I devices.

The Role of ISO 13485​

ISO 13485 is the internationally recognised standard for Quality Management Systems for medical devices. Holding a current, scoped ISO 13485 certificate issued by an accepted certification body is the most common way manufacturers demonstrate QMS compliance in Australia. However, ISO 13485 certification alone is not sufficient for all device classes — product-specific design dossier assessment is additionally required for Class IIb, Class III, and certain IVD classes.

MDSAP (Medical Device Single Audit Program)​

MDSAP is a program that allows a single audit of a medical device manufacturer to satisfy the regulatory requirements of multiple participating countries, including Australia, the USA, Canada, Brazil, and Japan. TGA accepts MDSAP certificates as evidence of a manufacturer's QMS for Australian applications. This can significantly reduce the audit burden for manufacturers selling across multiple markets.

Official Sources​