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

Published

24 October 2019

The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation.

This consultation was related to the implementation of the Australian Government Response to the 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) framework including in respect of the classification of medical devices.

A total of two (2) submissions were received.

TGA summary

This consultation invited respondents to provide feedback on a proposal to classify invasive medical devices that administer medicines or biologicals by inhalation as Class IIa (medium risk), unless their mode of action has an essential impact on the efficacy and safety of the administered therapeutic good or they are intended to treat life-threatening conditions, in which case they are classified as Class IIb (medium-high risk). The proposed changes would align the Australian classification with Rule 20 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU MD Regulation).

The submissions supported the proposed introduction of the new classification rules and it was noted that the changes will address a current lack of specific classification rules for these kinds of devices.

Respondents also commented on the importance of consistent interpretation and application of the EU MD Regulations and it was suggested that the terms "essential impact" and "life-threatening conditions" in the context of the proposed new classification rule should be clarified or defined in the Therapeutic Goods (Medical Devices) Regulations 2002.

There was support for the continued regulation of devices prefilled with medicines (e.g. multi-dose asthma inhalers) as medicines (i.e. not regulated as medical devices).

There were no objections to the proposed transitional arrangements.

This feedback will inform the work to develop the proposed regulatory amendments. Guidance material will be prepared to provide clarification about the devices that will be reclassified as a result of the regulatory changes and about the transitional arrangements.