Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media
The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media.
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 eight (8) submissions were received.
This consultation invited respondents to provide feedback on a proposal to classify non-invasive medical devices consisting of a substance, or a mixture of substances, intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body; or with human embryos, before their implantation or administration into the body, as Class III (high-risk). It was also proposed to incorporate a number of clarifying amendments into existing classification rules 2.2 and 2.3 in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (AU Regulations). The proposed changes would align the Australian classification of these devices with Rule 3 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU Regulation).
The responses to the proposal were mixed and indicate that further engagement with stakeholders about the medical devices regulatory framework is required.
Several submissions expressed concerns regarding particular groups of devices covered by the new proposed rule, specifically in relation to corneal and organ preservation media, and ex vivo media. There were concerns that the proposal will increase the cost and burden for manufacturers due to the additional regulatory requirements and subsequently may result in withdrawal of the products from the Australian market.
Concerns were also raised about blood bags; however, medical devices that are blood bags are not proposed to be reclassified and they will remain classified as Class IIb (in accordance with Rule 5.6 of Schedule 2 of the AU Regulations).
Some responses indicated a misinterpretation of the medical devices framework. In particular, it appeared that some respondents were not clear that the proposed reclassification will only impact products that are already regulated as medical devices and that it is not intended to apply to products that are not currently regulated as medical devices.
The TGA intends to undertake further targeted engagement with respondents to clarify the potential impact of the proposed changes and further develop the proposed regulatory amendments.
All submissions that gave permission to be published on the TGA website are available below in PDF format.
- Consultation submission: Monash IVF Group - Name only
- Consultation submission: Thermo Fisher Scientific - Name only
- Consultation submission: William A. Cook Australia - Name only