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Regulatory decisions & notices (medical devices & IVDs)
Regulatory decisions for medical devices & IVDs
- Medical devices and IVDs compliance actions
List of medical devices and IVDs subject to regulatory compliance actions
- Medical devices (including IVDs) designation notices
Designation allows the TGA to make a decision regarding whether a Medical Device (including IVDs) is eligible via the priority review pathway
- Regulation impact statements for medical devices
Links to regulation impact statements for medical devices
- Revocation of a TGA issued Conformity Assessment Certificate
Under section 41ES or 41ET of the Therapeutic Goods Act 1989, the Secretary may revoke a TGA issued conformity assessment certificate
Notices and advice for industry about medical devices & IVDs
- European implementation of Medical Device and IVD Regulations - Implications for Australia
26 May 2019: Information on Australian implications of European transition to new medical device and IVD regulations
- Medical device annual reporting - Sponsor obligations
15 May 2019: Sponsors of Class IIb (implantable), Class III devices, AIMD or Class 4 IVD to submit an annual report to the TGA by 1 October
- Brexit - Implications for therapeutic goods in Australia
6 March 2019: TGA will implement transitional arrangements for Brexit to ensure minimal interruption in the supply of therapeutic goods in Australia
- ISO 13485:2016 transition period ending
1 March 2019: Transition period for international standard ISO 13485 is ending
- Update: Increased audit requirements for medical devices using conformity assessment by selected European notified bodies
6 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.