Under the new framework, regulatory requirements which apply from 25 February 2021, will:
- introduce new definitions for personalised medical devices, thereby reducing the scope of the existing definition of a custom-made medical device;
- change the conditions of exemption for custom-made medical devices to:
- require annual reporting of custom-made devices supplied in the previous financial year;
- allow the TGA to inspect production facilities;
- require documentation about the device to be retained for 5 years (for non-implantable devices) or 15 years (for implantable devices); and
- require manufacturers to provide information about each custom-made medical device to the intended recipient.
- introduce the new concept of a Medical Device Production System (MDPS) and a framework for regulating these systems to allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification; and
- update the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purposes of recording patient anatomy for diagnosis and investigation, including anatomical models…
