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Medical devices reforms: Reclassification of certain medical devices

Project status: in progress

5 October 2021

News

On 25 November 2021, the reclassification of certain medical devices comes into effect. To continue to supply your device you must notify the TGA by 25 May 2022 that you have an inclusion to be reclassified.

Sponsors of Class IIb spinal fusion implantable devices need to provide the TGA with the name of their devices recorded in their ARTG entry. You can do this by accessing the new Class IIb product name variation form in your TBS portal. To ensure continued supply of your device, notifications should be made by 27 October 2021. This will allow 20 working days prior to the requirements coming into effect on 25 November 2021.

Project overview

The re-classification of certain medical devices will take effect from 25 November 2021. They are outlined in the table below.

Reform Old classification Revised classification
Active medical devices for therapy with diagnostic function IIa or IIb III
Spinal implantable medical devices IIb IIb or III
Devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system IIa III
Medical devices that administer medicines or biologicals by inhalation I or IIa IIa or IIb
Active implantable medical devices (AIMD) AIMD III
Medical devices that are substances introduced into the body via body orifice or applied to the skin I or IIa IIa, IIb or III

A transition period is available for existing medical devices:

  • included in the ARTG prior to 25 November 2021. You will need to notify the TGA before 25 May 2022 that you have an inclusion to be reclassified.
    • if you are the sponsor of a Class IIb spinal fusion implantable device, you also need to update product names in your ARTG entry by 27 October 2021. This will allow the required 20 working days prior to 25 November 2021 to ensure there is no interruption in supply.
  • with applications for inclusion in the ARTG lodged before 25 November 2021. Your application will be assessed, and the device included in the ARTG under the old classification rules. You will need to notify the TGA that you have an inclusion to be reclassified by whichever is the later date, before 25 May 2022 or within 2 months of the start date of your ARTG entry.

Applications for medical device inclusions submitted on or after 25 November 2021 must be submitted according to the new classification rules.

How to notify TGA

  1. Read the guidance for your device category.
  2. Click on the notification link for your device category, follow the instructions to complete and submit your notification.

Please be aware, notification forms are different for each device category. Ensure you select the correct notification link.

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

The response of stakeholders were broadly supportive of aligning the Australian medical devices framework with the EU framework.

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

The TGA continued to consult regarding the proposed changes to reclassification, prior to considering regulatory amendments for this category of devices.

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.

Stakeholders were consulted through rounds of public consultations from April 2019 to July 2021 Feedback on proposed amendments helped us identify potential issues, tailor stakeholder engagement programs and refine amendments.

Consultations

Consultation Status

Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

Consultation closed 13 August 2021

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.