Medical devices reforms: Conformity assessment bodies

Project overview

Australian corporations can apply for an Australian conformity assessment body (Australian CAB) determination and issue conformity assessment certification for medical devices under Australian law.

Conformity assessment is the systematic and ongoing examination of evidence and the application of procedures to ensure a medical device complies with the essential principles for medical devices. Evidence that a device has undergone an appropriate conformity assessment procedure must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG).

Previously, Australian medical device manufacturers could only apply for a conformity assessment certificate from either the TGA or an overseas Notified Body.

To provide additional flexibility and timeliness, the Australian Government agreed to regulatory changes that allow other Australian corporations that demonstrate appropriate experience and competence to undertake conformity assessment of medical devices. An Australian CAB must demonstrate they can perform product assessments and quality management system audits under the Australian conformity assessment body framework.

The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG).

For more information about the Australian conformity assessment body determination process, see Australian conformity assessment bodies.

For more information about acceptable documentation and the submission of a valid ARTG application see Manufacturer evidence for medical devices and IVD medical devices and Medical device inclusion process.

For general privacy information about the personal information in or in relation to applications for conformity assessment body determinations, see: Privacy.

Applications

Application form for an Australian conformity assessment body determination

Guidance for industry

For guidance on how to become an Australian conformity assessment body see Determinations for Australian conformity assessment bodies.

For a list of Australian conformity assessment body determinations made by the TGA, see Australian conformity assessment bodies.

For guidance on conformity assessments, see Australian regulatory guidelines for medical devices (ARGMD) - Conformity assessment.

For legislation, see Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 Schedule 2, Part 4-4A - Australian conformity assessment bodies.

For regulatory change, see Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 Schedule 3, Part 4A - Australian conformity assessment bodies.

Consultations

For more information see Consultations and reviews.