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Medical device reform regulation amendments - 16 December 2019

Overview: Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019
These regulatory amendments support broader implementation of the medical device reforms initiated by the Expert Review of Medicines and Medical Devices Regulation. Further regulatory changes will occur in 2020. This follows a number of public consultations conducted in late 2018 and early 2019. More detailed guidance will be provided for industry in early 2020.

The Governor-General in Council made regulations to delay the commencement of a number of these medical device reforms to reflect the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis. The regulations which implement the delay commenced on 23 July 2020.

Medical devices reforms

An Action Plan for Medical Devices

On 4 April 2019, the 'Action Plan for Medical Devices' was released.

Whilst the regulatory requirements in Australia are some of the most stringent in the world, more can be done to further strengthen the system, placing patient safety first.

The Action Plan is a three part strategy to:

• improve how new devices get on the market in Australia
• strengthen monitoring and follow up of devices already in use
• provide more information to patients about the devices they use

The Action Plan provides an overview of the current regulatory system, what actions are proposed and the timeframes for these.

It will fast track TGA's implementation of medical device reforms already underway and consult on new ways to improve transparency and increase public and health professional confidence in the regulatory system. Involving consumers in the process is critical, noting that decisions on new policies or changes to the Therapeutic Goods Act will be required from the Parliament prior to potential implementation.

The TGA has been tasked with providing more detail on how the actions outlined in the Plan could be implemented, engage and consult with consumers and other stakeholders so that they have input to implementation.

An emphasis of the Plan is to introduce more transparency by the TGA and that greater scrutiny occurs throughout the whole device lifecycle.

• Action Plan for Medical Devices
  More detailed information on each of the strategies in the Plan and proposed consultations will be published in the near future

Reclassification of surgical mesh devices

• Reclassification of surgical mesh devices
  From 1 December 2018, all new 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.

Patient implant cards and consumer device information leaflets

• Patient implant cards and consumer device information leaflets
  From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted) will need to provide patient implant cards and have a consumer device information leaflet, as part of new consumer information requirements.

Reclassification of certain medical devices

• Reclassification of certain medical devices
  From 25 November 2021, six categories of medical devices will be reclassified to align with the European Union's Medical Device Regulations, including:
  • spinal implantable medical devices
  • active implantable medical devices
  • medical devices that administer medicines or biologicals by inhalation
  • medical devices that are substances (or combinations of substances) for introduction into the body
  • active medical devices for therapy that include a diagnostic function to significantly determine patient management, and
  • medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system

Medical device software and personalised medical devices

• Medical devices software and personalised medical devices
  From 25 February 2021, regulations will commence to improve the way custom made devices and software as a medical device are regulated.

Systems or procedure packs

• Systems or Procedure Packs
  From 25 August 2020, the new definition of 'system or procedure pack' and minor consequential amendments to the requirements for system or procedure packs in Therapeutic goods (Medical Devices) Regulations 2002 to reflect the new definition of these products in the Therapeutic Goods Amendment (2020 Measures No.1) Bill 2020 will commence. Noting these minor amendments will not involve any changes to obligations for sponsors or manufacturers.

  From 25 November 2021, other changes to the requirements for systems or procedure packs in the Therapeutic goods (Medical Devices) Regulations 2002 will commence.

  Detailed guidance will be made available to stakeholders to clarify obligations for sponsors and manufacturers resulting from the changes to the Regulations.

Essential Principles

• Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation have been delayed for up to two years after the commencement of European Union Medical Device Regulation (i.e. May 2023). The changes to the Essential Principles will apply to both medical devices and IVD medical devices.

Pre-market assessment of medical devices reforms

The TGA is implementing a series of medical device regulatory reforms increasing the rigour of pre-market assessment of higher risk medical devices, to assure the quality, safety and performance of these devices.

Further information on key reforms is available from:

• Reclassification of hip, knee and shoulder joint replacements
• Australian medical device manufacturers
• Increased scrutiny of medical devices
• Product names
• Regulation impact statement: Premarket assessment requirements for Australian manufactured medical devices

IVD medical devices reforms

Extension to the timeframe for the transition to the IVD regulatory framework

The current regulatory framework for in vitro diagnostic medical devices (IVDs) was introduced in 2010 via amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The provisions included a 4-year transition period for IVDs supplied in Australia prior to 1 July 2010, with all such IVDs required to comply with the new requirements by 1 July 2014.

Due to difficulties encountered during the transition period, the TGA proposed an extension to the timeframe. An extension has now been made through amendments to those regulations. The new deadlines to demonstrate compliance with the IVD regulatory framework are summarised in the table below. They will come into effect immediately before 1 July 2014.

The new transitional provisions do not apply to any product that was supplied prior to 1 July 2010 and since this date, has been the subject of an application for inclusion in the Australian Register of Therapeutic Goods (ARTG) under Chapter 4 of the Therapeutic Goods Act 1989 that was rejected. These products cannot be legally supplied after 30 June 2014 unless they are included in the ARTG.

There is no annual charge for IVDs included in the ARTG under Chapter 4 of the Act for the 2013-2014 financial year. This exemption will continue to the end of the 2016-2017 financial year when the transition period ends.

1. An application is considered to be effective once the prescribed application fee has been paid.

If you require further information on the timeframe extension please email, devicereforms@tga.gov.au.