Medical devices & IVDs (closed consultations & reviews)
The following consultations and reviews are closed for comment.
- Consultation: Proposed regulatory changes related to personalised and 3D printed medical devices
Consultation on future options for the regulation of personalised and 3D printed medical devices. Closed: 22 December 2017
- Consultation: Alignment with European medical device regulatory framework: Up-classification of surgical mesh & Patient implant cards
Consultation on proposed changes to up-classify all surgical mesh medical devices to Class III and to provide patient implant cards (and consumer product information) for all implantable medical devices. Closed: 25 August 2017
- Consultation: Comparable overseas regulators - medical devices Consultation on the use of medical devices approvals from comparable overseas regulators. Closed: 30 June 2017
- Consultation: Designation of Australian conformity assessment bodies for medical devices - implementation
Consultation on designation of Australian conformity assessment bodies for medical devices. Closed: 11 January 2017
- Consultation: Accelerated assessment of medical devices - Priority Review pathway - Implementation
Consultation on accelerated assessment of medical devices - Priority Review pathway. Closed: 11 January 2017
- Consultation - Software as a Medical Device (SaMD): Clinical Evaluation
Consultation on draft IMDRF document. Closed: 2 December 2016
- Consultation: Draft clinical evidence guidelines - Medical devices
Consultation on the draft medical devices clinical evidence guidelines. Closed: 10 June 2016
Older consultations & reviews are available in the TGA Internet site archive.