Australia’s Therapeutic Goods Administration invited comments on its proposed regulatory scheme for personalized and 3D-printed medical devices.
The agency asked devicemakers to comment on three possible options for overhauling the regulations, one of which includes a comprehensive package of reforms. Another option would regulate custom-made devices in line with other medical devices. The third option would be to make no changes for personalized and 3D-printed medical devices.
The guidance includes a table that lists the differences between custom-made medical devices, patient-matched medical devices, adaptable medical devices and non-adaptable mass-produced devices.