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Medical devices reforms: Reclassification of certain medical devices

News

On 23 July 2020, the Governor-General in Council made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.

The Australian Medical Device Regulations have been amended to delay implementation of some reclassification reforms from 25 August 2020 to 25 November 2021.

Transitional arrangements may apply to devices that are:

  • already included in the ARTG as at 25 November 2021; or
  • the subject of an application for inclusion in the ARTG submitted to the TGA prior to 25 November 2021 and the application fee has been paid.

Project status: in progress

12 May 2021

Project overview

The TGA is considering certain devices and their current classification - particularly where there have been safety issues identified and/or where the European Union has made changes to its classification systems. Our aim is to where possible and appropriate, harmonise the Australian classification rules to safeguard patients, harmonise requirements, facilitate smooth operation of the market and ensure timely access to medical devices.

In early 2019, the TGA undertook public consultations on proposals to reclassify a number of categories of medical devices so that they align, wherever possible, with the changes being introduced in European Union (EU) medical devices framework.

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 were made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six categories of medical devices:

  • spinal implantable medical devices
  • active medical devices for therapy with diagnostic function
  • active implantable medical devices and their accessories
  • medical devices that administer medicines or biologicals by inhalation
  • medical devices that consist of substances introduced into the body via a body orifice or applied to the skin
  • medical devices used in direct contact with the heart, central circulatory or central nervous systems.

The TGA will continue to consult regarding the proposed medical device classification for storage solutions for human cells, tissues and organs, and IVF media in order to clarify issues raised in submissions, prior to considering regulatory amendments for this category of devices.

For more information on what changes are being made see:

Guidance for industry

Guidance is in development to include further information about the reclassifications and transitional arrangements for devices that are currently included in the ARTG.

Five draft guidance documents were provided to the Regulatory and Technical Consultative Forum for medical devices in June 2020 for feedback to inform the final guidance documents.

Further information and guidance about the new classification rules and transitional arrangements will be published as it becomes available.

Consultations

Consultation Status

Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

Consultation closed 29 April 2019

Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation closed 29 April 2019

Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation closed 29 April 2019

Proposed changes to the classification of active implantable medical devices and their accessories

Consultation closed 29 April 2019

Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation closed 29 April 2019

Proposed reclassification of spinal implantable medical devices

Consultation closed 29 April 2019

For more information see Consultations and reviews.

Keep up to date

Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.