AMA submission to the Therapeutic Goods Administration – Proposed refinements to the regulation of personalised medical devices
In this submission, the AMA recognises new challenges the TGA faces relating to a rapid increase in innovative technologies that mean new professions can be defined as manufacturers of medical devices.
The AMA understands that the recent regulatory reform has resulted in a duplication of regulation across multiple regulatory bodies for some medical devices. The AMA supports the proposed refinements to Class I non-sterile, non-measuring patient matched medical devices and Class IIa patient matched medical devices, provided several principles are met, such as that devices are regulated once, with the TGA remaining the default/primary regulator. The AMA opposed excluding certain patient-matched medical devices on the grounds of patient safety.