The Australian Therapeutic Goods Administration (TGA) has released more medical device related regulatory guidance as the agency continues to reform its medical device regulations.
Following the implementation on 25 February 2021 of the new framework governing personalised medical devices, the TGA has now published a frequently asked questions (FAQ) page to provide as much guidance as possible to manufacturers. The FAQ page is designed to be read in conjunction with a guidance document on the regulatory changes to personalised medical devices which was initially released at the end of December 2020.
Additionally, the TGA has launched a consultation on its proposed regulatory options for medical devices containing nanomaterials. The consultation is being conducted in response to the European Union Medical Device Regulations (EU MDR) which contains new requirements surrounding the use of nanomaterials in medical devices. Three potential options have been identified:
- Make no changes
- Make requirements explicit – add definitions (to the dictionary of the Australian Medical Device regulations) and amend essential principles to specify the requirement to consider and manage the risks linked to nanomaterial particle release into the user’s body
- Add new classification rules
For each potential option, the TGA highlights what would change for sponsors and manufacturers. The consultation closes on 09 April 2021.