Regulation Impact Statement – Therapeutic Goods Administration
On 12 December 2019, the Minister for Health amended the Therapeutic Goods (Medical Devices) Regulations 2002 to incorporate reforms to the Australian medical devices regulatory framework.
The amendments address the rapid emergence of new technologies and rapid uptake of personalised medical devices; the continued need for international alignment; and the lack of suitable alternative mechanisms to manage issues with personalised medical devices.
The amendments:
- reduce the scope of the existing definition of custom-made medical device;
- introduce new definitions in relation to personalised medical devices;
- change the exemption requirements for custom-made medical devices to:
- require annual reporting of custom-made devices supplied in the previous financial year;
- allow the Therapeutic Goods Administration (TGA) to inspect production facilities;
- require documentation about the device to be retained for 5 years (for non‑implantables) or 15 years (for implantables);
- require manufacturers to provide information about each custom-made medical device to the intended recipient;
- introduce a new concept of Medical Device Production System (MDPS) and a framework for regulating medical device production systems which will allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification; and
- update the classification rule 5.4 for medical devices that record diagnostic images to include non-visible spectrum imaging mechanisms for this purpose and not just X-rays, and also include models of patient anatomy.
The TGA prepared and certified a Regulation Impact Statement (RIS), which the Office of Best Practice Regulation assessed as compliant with the Australian Government RIS requirements and consistent with best practice. The RIS estimated the average annual increase in regulatory costs at $1.27 million a year.