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

Published

31 October 2019

The TGA thanks respondents who provided a submission in response to the public consultation paper: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin.

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 twelve (12) submissions were received.

TGA summary

This consultation invited respondents to provide feedback on a proposal to introduce a new specific classification rule for medical devices that are composed of substances (or combination of substances) that are intended to be introduced into the human body via a body orifice or applied to skin that are absorbed by or locally dispersed in the human body. These devices will be classified as Class IIa (low-medium risk), Class IIb (medium-high risk), or Class III (high risk) depending on the location in the body where the device achieves its intended purpose.

The proposed changes would align the Australian classification of these devices with Rule 21 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU MD Regulation). It was also proposed that the definition of 'injured skin or mucous membrane' in the EU MD Regulation be incorporated in the Therapeutic Goods (Medical Devices) Regulations 2002 (AU MD Regulations).

There was general support for the proposed alignment of the Australian classification rules with the EU MD Regulation. However, several submissions queried the scope of devices that should be subject to the proposed classification rule (e.g. eye irrigation/washing solutions and dentifrices/toothpaste).

There was general support for the proposal to define the term 'injured skin or mucous membrane'. Some respondents also suggested that the terms 'systemically absorbed' and 'locally dispersed' be defined or clarified.

Some submissions raised concerns about the possibility of the proposed new classification rules resulting in a reduction of available products on the Australian market. However, there were also comments that such rationalisation reduction could be beneficial as it could remove ineffective products from the market.

Some submissions also raised questions that were not within the scope of the consultation paper.

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.