Conformity assessment is the systematic and ongoing examination of evidence and 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). Australian medical device manufacturers need to apply for a conformity assessment certificate from either the Therapeutic Goods Administration (TGA) or a Notified Body overseas.
Timeframe for TGA to complete a conformity assessment is 255 days. To provide additional flexibility and timeliness, the Australian Government agreed on regulatory changes that allow other designated bodies within Australia to undertake conformity assessment of medical devices. The aim is to allow approved Australian corporations to operate an Australian Conformity Assessment Body (AU CAB) and issue conformity assessment certification for medical devices under Australian law.
Australian corporations can apply to become an Australian Conformity Assessment Body (AU CAB) from July 1st, 2021. The determination of an AU CAB requires demonstrated competency and recognition for undertaking medical device conformity assessments and quality management system auditing. It is expected that an AU CAB will be an Australian-based corporation operating under the systems and controls that have already been assessed as compliant by comparable overseas regulators through their parent and affiliated organization’s recognition, such as a Notified Body under EU MDR or EU IVDR, and as an MDSAP Auditing Organisation.
The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG). While the TGA can designate bodies within Australia to undertake conformity assessment of medical devices, the details and guidance on the process are still being finalized. In this context, TGA is also considering the new redesignation arrangements for Europe Notified Bodies. For regulatory changes, please refer to Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 Schedule 3, Part 4A - Australian conformity assessment bodies.
Medical devices reforms: Conformity assessment bodies
Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018
Part 4A - Australian conformity assessment bodies