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) priority applicant determination notices
  A priority applicant determination expedites a process of TGA conformity assessment or an application for inclusion in the Australian Register of Therapeutic Goods (ARTG)
• 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

The TGA will continue to publish information about medicines and medical devices as it relates to COVID-19 on a regular basis: Coronavirus (COVID-19): Information on medicines and medical devices.

2021 2020 2019 2018

2021

• Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices
  25 January 2021: On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the ARTG changed

2020

• Updates to electronic application for a Conformity Assessment Certificate
  20 November 2020: The electronic application form for a Conformity Assessment Certificate has been updated
• New compliance dashboard for post-market medical device reviews
  13 October 2020: From 19 October 2020, the process by which the TGA engages with sponsors will change.
• Update to medical device definitions and requirements for system or procedure packs
  25 August 2020: Information for sponsors and manufacturers about some new definitions and requirements commencing on 25 August 2020
• Exporting a ventilator: A fact sheet for Australian sponsors and manufacturers
  12 August 2020: Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia
• Delays to the commencement of certain medical device regulatory changes
  23 July 2020: The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia
• Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019
  23 July 2020: This is the first package of regulatory changes for the broader medical device reforms
• Reduced annual charges for medical devices listed on the prostheses list
  2 July 2020: The government has agreed to provide a 50 per cent reduction in annual charges for certain medical devices for the 2020-21 financial year
• European implementation of Medical Device and IVD Regulations - Implications for Australia
  16 June 2020: Information on Australian implications of Europe's transition to new medical device and IVD regulations

2019

• 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

2018

• Reclassification of surgical mesh medical devices
  27 November 2018 From 1 December 2018, all new applications for surgical mesh devices (including urogynaecological mesh devices) seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device.
• 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.