While the consultation is open you can make a submission at our TGA Consultation Hub. We will then review the submissions. After that, a summary of responses will be published on the same page at the TGA Consultation Hub.
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.
The TGA periodically reviews requirements for medical devices to ensure they continue to be appropriate. When undertaking such reviews, we have regard to the risks and whether those risks have changed over time, international best regulatory practice, and any emerging issues.
The TGA has received requests to review the risk classification of medical devices that contain certain materials from animal, microbial or recombinant origin.
Currently, under the Australian medical device regulatory framework, the TGA regulates medical devices that contain tissues, cells, or substances of animal, microbial or recombinant origin as Class III (high risk) medical devices under rule 5.5, Schedule 2 – Classification rules for medical devices other than IVD medical devices of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
In 2002, when the Medical Device Regulations were established, the risks associated with these ingredients were considered high. Taking into account new and existing feedback from previous consultations, this consultation now seeks to review the regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin to determine whether any changes should be made.
Why your views matter
We are seeking your views about whether the current classification rule and the corresponding conformity assessment procedures continue to be appropriate given the risk status of such products. We seek your feedback on:
the risk of certain materials of animal, microbial or recombinant origin
microbial and recombinant materials in general
accepting evidence from a broader range of comparable overseas regulators for these medical devices.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.