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

We asked for feedback on potential refinements to the Regulations in relation to classification rules for medical devices that are substances introduced into the human body via a body orifice or applied to the skin.

A total of 45 submissions were received. They comprised of 17 from the medical device or medicine industry (manufacturers, sponsors or peak body associations) and 28 from consumers.

The 28 responses from consumers have been noted but have not been taken into account in this consultation. It appears these respondents misunderstood the intent of the consultation due to social media incorrectly suggesting the consultation was in relation to microchipping individuals.

Of the remaining 17 respondents, the majority (11) did not support the proposal to refine the Regulations. While, the other six respondents supported the proposed refinements.

There seemed to be a general misunderstanding of the consultation and types of devices covered by the relevant classification rule. Some respondents were unsure how their product would be regulated under the proposed refinement, and some did not support the proposal if it meant their products would become a medicine. Some respondents raised issues that were not directly related to the questions in this consultation, including concerns about the interface between medical devices and foods. The intent of the proposed refinement to the classification rule was not for products to change regulatory pathways, but rather to provide clarity about which pathway the product should take (i.e. medicine or medical device).

Some respondents believed there would be an increased regulatory burden should the classification rule be amended. They believed that Australia would not align with Europe. Where sponsors may not have the resources to support a product to be regulated as a medicine in Australia, whilst the same product would be regulated as a medical device in Europe. Some respondents also noted that Australian patients may miss out on a number of products if there was a change in the regulatory pathway. Not all sponsors would continue to supply the product if it deviated from other major markets in its classification and regulatory pathway.

Importantly, some respondents did not appreciate that:

• any product that is a substance-based medical device will be a Class IIb device instead of a Class III device (so it represents lower regulatory burden than in Europe); and
• the mode of action will be reviewed should the product appear to not meet the definition of a medical device as defined in the Therapeutic Goods Act; and
• without the proposed refinement, from 25 November 2021, some products would be reclassified to Class III devices and the regulatory burden increased.

This consultation strongly highlighted that clarification was urgently needed on this topic, including on a number of other matters in relation to this classification rule and definitions. There is an urgent need to clarify and provide a definition for absorption, chemical action and physical barriers, both of which help determine whether a product should be regulated as a medicine or medical device.

Whilst industry concern over misalignment with Europe and their Medical Device Regulations were noted, the Australian regulatory framework and definitions are different to those in Europe. The proposed refinements to the Medical Device Regulations (as set out in the consultation paper) would not have the effect of pushing any of these products to be considered as medicines – the proposed refinements would principally reduce some of the confusion in the language of the device classification rules and avoid any such products being up-classified to the Class III level.

Based on the outcomes from the consultation, agreement will be sought from the Government to consider refinements to the Regulations. These refinements would remove reference to products that are systemically absorbed and provide clarity around the regulation of these products.

Guidance will be further updated post a decision from Government on the proposed refinements and to address other concerns raised in this consultation as well as continued education in relation to the regulation of products containing substances.