Medical devices reforms: conformity assessment bodies

Project overview

Conformity assessment is the systematic, ongoing review of evidence and procedures to ensure a medical device (including IVD medical devices) complies with the Essential Principles. 

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.

Regulatory changes now allow other Australian corporations to undertake conformity assessment of medical devices.

An Australian CAB must have appropriate experience and competence to undertake conformity assessment of medical devices. They 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).

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 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- external site - external site Schedule 2, Part 4-4A - Australian conformity assessment bodies.

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

Consultations

More information

• Australian conformity assessment bodies
• Determinations for Australian conformity assessment bodies
• Manufacturer evidence for medical devices and IVD medical devices 
• Medical device inclusion process
• Privacy
• Australian regulatory guidelines for medical devices (ARGMD) - Conformity assessment