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Medical devices reforms: Conformity assessment bodies
Project status: in progress
Determination of Australian Conformity Assessment Bodies
Australian corporations can apply to become an Australian Conformity Assessment Body (AU CAB) from 1 July 2021.
The TGA will publish information about how to apply, an online application form and guidance on the designation / determination criteria and scope of medical devices for which an AU CAB can issue a conformity assessment certificate. The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG).
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 organisation’s recognition, such as a Notified Body under EU MDR or EU IVDR, and as an MDSAP Auditing Organisation.
The aim is to allow approved Australian corporations to operate an Australian Conformity Assessment Body and issue conformity assessment certification for medical devices under Australian law.
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 TGA or a Notified Body overseas.
The TGA's legislative timeframe for completing a conformity assessment is 255 days. To provide additional flexibility and timeliness, the Australian Government agreed to regulatory changes that allow other designated bodies within Australia to undertake conformity assessment of medical devices. 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 finalised. In this context, we are also considering the new redesignation arrangements for Europe Notified 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.
Guidance for industry
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.
|Designation of Australian conformity assessment bodies for medical devices - Implementation||Consultation closed 11 January 2017|
For more information see Consultations and reviews.