Regulatory decisions & notices (medical devices & IVDs)
6 June 2018
Regulatory decisions for medical devices & IVDs
- Medical devices and IVDs compliance actions
List of medical devices and IVDs subject to regulatory compliance actions
- Regulation impact statements for medical devices
Links to regulation impact statements for medical devices
Notices and advice for industry about medical devices & IVDs
- Update: Increased audit requirements for medical devices using conformity assessment by selected European notified bodies
xx June 2018: TGA no longer considers it necessary to apply increased audit requirements to particular European notified bodies.
- Optimising Class I medical device entries
29 May 2018: Information sheet to assist sponsors to optimise their Class I ARTG listings to minimise the number of entries necessary, while also complying with the therapeutic goods regulatory requirements.
- Revocation of a legislative instrument
26 March 2018: The Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2017 (Order) was registered as a notifiable instrument on the Federal Register of Legislation on 18 August 2017 and commenced the day after registration. The Order declared that 'a material or other article that through chemical means is intended to change, or acts by causing change to, the pH levels of the body fluids, including a body orifice, is not, for the purposes of the Act, a medical device'. On 5 January 2018, a decision was made to revoke the Order. For that purpose, a separate notifiable instrument has now been registered which formally revokes the Order.
- Automatic conditions for medical devices - legislative amendments
14 July 2017: Legislative amendments have come into effect that automatically impose a number of standard conditions on all medical device entries in the ARTG. These conditions relate to storage and transport requirements, record keeping, annual reporting, and notification of information relating to certain IVD medical devices.
- Annual Charges for IVDs effective from 1 July 2017
8 June 2017: Annual charges for IVDs included on the Australian Register of Therapeutic Goods (ARTG) will commence from 1 July 2017. The annual charge per ARTG entry for the 2017/2018 financial year will be $660 for all classes of IVDs.
- Medical device quality management systems: transition to new standard
8 December 2016: In March of this year the International Organization for Standardization (ISO) published a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003.<
- Annual charges for IVDs effective from 1 July 2017
21 July 2016: The transition period for the in vitro diagnostic medical devices (IVDs) regulatory framework will cease on 30 June 2017. During the transition period there are no annual charges for entries in the Australian Register of Therapeutic Goods (ARTG) for IVDs. Annual Charges will commence from 1 July 2017. Further information on the proposed annual charges for IVD medical devices will be provided when available. For information on current fees for applications for conformity assessment or inclusion in the ARTG, please refer to Summary of fees and charges from 1 January 2016.
- New Tyvek® materials: regulatory obligations
22 January 2016: In order to meet the conditions of inclusion on the ARTG, manufacturers need to check that the performance and safety of their medical devices continue to meet the Australian Essential Principles (EPs)
- TGA pilot of IMDRF Table of Contents for medical device submissions
4 December 2015: The TGA is participating in the pilot program to trial the ToCs for conformity assessment pre-market applications
- Amendments to the regulatory framework for in vitro diagnostic medical devices (IVDs)
16 November 2015: Amendments have now taken effect and a summary is provided
- Joint replacement definition - regulatory amendment
20 April 2015: A regulatory amendment has been enacted to include definitions of hip, knee and shoulder joint replacement medical devices and related ancillary devices, as part of the reclassification of joint replacement medical devices
- Reclassification of hip, knee and shoulder joint implants
8 July 2015: Total and partial hip, knee or shoulder joint implants were reclassified as Class III medical devices on 1 July 2012
- IVD term development handover to GMDN Agency
19 December 2014: The TGA assisted industry by ensuring that relevant preferred terms (PTs) and collective terms (CTs) were available in the GMDN database for their IVDs
- Declaration that certain IVDs are medical devices
18 December 2014: The TGA has finalised a legislative instrument to ensure that certain pathology tests and related instrumentation are regulated as medical devices
- Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)
17 October 2014: The TGA has finalised the regulation impact statement that outlines amendments to the regulatory framework for in vitro diagnostic medical devices
- HIV self-tests in Australia: Supply restrictions lifted
9 July 2014: The Secretary of the Department of Health has signed the legislative instrument to amend the Therapeutic Goods (Excluded Purposes) Specification 2010 to allow the future supply of HIV self-tests
- Joint reclassification advice: Extension of the timeframe for TGA to select a reclassification application for audit
4 July 2014: A regulatory amendment has been enacted to extend the timeframe for an application for reclassification of a joint implant to be selected for audit from 20 working days to 60 working days.
- Conformity assessment and summary technical reports for Class III medical devices
17 June 2014: This guidance is intended for applicants (the sponsors) seeking ARTG inclusion for Class III medical devices that are of a lower classification in Europe
- Joint reclassification advice: Transition timeframe extended to June 2015
29 April 2014: On 24 April 2014, a regulatory amendment was enacted to extend the transition period by one year to 30 June 2015 for the reclassification of partial and total hip, knee and shoulder joint replacements