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Outcomes of reclassification of a number of medical devices following consultations in 2019
Update - 23 July 2020
The Governor-General in Council has 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 delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms.
You can find out more information at: Delays to the commencement of certain medical device regulatory changes
The TGA thanks respondents who provided submissions in response to the consultations published in early 2019, relating to the proposed reclassification of a number of categories of medical devices.
The consultations related to the implementation of the Australian Government Response to the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) medical devices framework including in respect of the classification of medical devices.
Summaries of the submissions received and copies of submissions that gave permission to be published on the TGA website are now available:
- Submissions received: Proposed reclassification of spinal implantable medical devices
- Submissions received: Potential reclassification of active medical devices for diagnosis and patient therapy
- Submissions received: Proposed changes to the classification of active implantable medical devices and their accessories
- Submissions received: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
- Submissions received: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin
- Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems
- Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media
There was broad support for the proposals to align the Australian classification of medical devices with the EU regulation on medical devices (Regulation (EU) 2017/745) (EU MD Regulation). For the majority of consultations, there was support for the proposed changes as outlined in each of the consultation papers. Some of the issues raised by respondents related to the lack of clarity in some EU classification rules, limited published material outlining the European Commission's (EC) rationale relating to these rules, and the importance of consistency and accuracy when interpreting the rules. Respondents also offered useful feedback on implementation and transition considerations if the proposed changes were adopted in Australia.
For two of the consultations, relating to spinal implantable medical devices and accessories to active implantable medical devices (AIMD), there was a diverse range of views. The TGA therefore undertook further consultation with targeted respondents about the proposed classification changes and regulatory requirements for these groups of devices.
Following the targeted consultation, the classification rule for spinal implantable medical devices has been refined to clarify that an implantable medical device that is a motion-preserving device, such as a spinal disc replacement, or any implantable device that comes into contact with the spinal column, will be classified as Class III. However, implantable instrumentation such as rods, plates, screws, cages, or hooks, which are intended to be used during spinal fusion surgical procedures, will continue to be classified as Class IIb. To ensure that there is transparency about specific devices being supplied under the Class IIb ARTG entries, sponsors will be required to provide information to the TGA about the product names of the devices that are supplied under the ARTG entry. In addition, a new requirement will be introduced that will result in new Class IIb inclusion applications being subject to audit.
Following post-consultation targeted discussions regarding accessories to AIMD, only long-term surgically invasive and implantable accessories to AIMD will be classified as Class III, rather than all accessories to AIMD (Note: implantable accessories to AIMD and active devices intended to control, monitor or directly influence the performance of an AIMD are already classified as Class III).
For the remaining four proposals, the regulatory amendments to align the Australian classification of medical devices with the EU MD Regulation will proceed. Some submissions to the consultations queried the scope of devices that are proposed to be reclassified. The TGA will prepare guidance material that takes into consideration the issues and rationale that were submitted to the TGA to provide clarification about the scope of devices that will be reclassified as a result of the regulatory amendments. For example, some respondents to the consultation about active medical devices for therapy with integrated diagnostic function considered that due to the nature of the therapy, continuous positive airway pressure (CPAP) machines should remain classified as Class IIa. In this respect, TGA agrees with the rationale and risk-based assessment put forward by respondents and this will be reflected in the guidance material that will be prepared.
Where to from here?
The TGA has refined the proposals and the Government has endorsed the proposed changes. The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six (6) categories of medical devices, out of the seven (7) proposals. The regulatory amendments will come into effect on 25 August 2020 with a four-year transition period to the end of 31 October 2024. Further information about the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 is available at: Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019.
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 the issues raised by respondents prior to considering regulatory amendments for this category of devices.
The feedback from the consultations will continue to inform the work to develop guidance material, which will include information about the devices that will be subject to reclassification and provide further information about the transitional arrangements to reclassify devices that are currently included in the ARTG.