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Conditions of Inclusion

Overview​

Inclusion in the ARTG is not unconditional. Every ARTG entry is subject to statutory conditions of inclusion set out in the Therapeutic Goods Act 1989 and the MD Regulations, as well as any additional conditions the TGA may impose on specific entries. Conditions of inclusion are ongoing obligations that apply for as long as the device is included in the ARTG. Breaching a condition of inclusion can result in suspension or cancellation of the ARTG entry.

Statutory Conditions of Inclusion​

The following conditions apply to all medical device ARTG entries by operation of law:

Continued compliance with Essential Principles The device must continue to meet all applicable Essential Principles for its full period of supply in Australia. If a design or manufacturing change affects Essential Principles compliance, this must be assessed and evidence updated before continuing to supply the device.

Conformity assessment evidence remains current The manufacturer's conformity assessment evidence (QMS certificates, product certificates) must remain valid and in scope. If a certificate lapses, is suspended, or is revoked, the sponsor must notify the TGA. Supply must cease until replacement evidence is accepted.

Adverse event reporting The sponsor must report adverse events and near adverse events to the TGA through IRIS within the required timeframes. Failure to report is a breach of conditions of inclusion.

Maintenance of distribution records The sponsor must maintain distribution records sufficient to enable an effective recall of the device from all locations it has been supplied to.

Sponsor-manufacturer written agreement The written agreement between the sponsor and manufacturer must remain in place and must enable the sponsor to obtain technical and regulatory information from the manufacturer within required timeframes.

Notification of significant changes If a significant change is made to the device (design, intended purpose, materials, manufacturing, labelling), the sponsor must notify the TGA and determine whether a variation application or new ARTG application is required.

Compliance with advertising requirements All advertising for the device must comply with the Therapeutic Goods Advertising Code. Claims must be consistent with the device's ARTG entry.

Annual charge payment Annual charges must be paid when invoiced. Non-payment results in cancellation of the entry.

TGA-Imposed Conditions​

In addition to statutory conditions, the TGA may impose specific conditions on individual ARTG entries. These might include:

  • Requirements to conduct post-market clinical follow-up studies
  • Mandatory reporting on specific safety parameters
  • Restrictions on the intended use or patient population
  • Conditions related to labelling or supply restrictions

TGA-imposed conditions are set out in the inclusion approval letter. Sponsors must be aware of and comply with any conditions specific to their ARTG entry.

Variation Applications​

If changes occur that affect the information in an ARTG entry, the sponsor must submit a variation application. Common variation triggers include:

  • Change of sponsor
  • Change of manufacturer name or address
  • Addition of new device models or variants to the entry
  • Changes to the device's intended purpose or classification

Not all changes require a variation — the TGA publishes guidance on when a variation is required versus when a change can be notified without a formal application:

👉 Varying an ARTG entry — TGA

Official Sources​