Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically. Higher risk custom-made medical devices, including orthopedic implants, are now available and their continued supply under the custom made medical devices exemption requires independent oversight.
The Therapeutic Goods Administration (TGA) has conducted extensive consultation and liaison with members of industry and other global regulators, designing a new framework for medical devices that are designed and manufactured for individual patients. Collectively these changes are known as the “personalized medical devices framework”. The framework has been introduced by the Australian Government to ensure an appropriate level of regulation is applied to personalized medical devices in order to manage the risks associated with their use.
Under the new framework, regulatory requirements which apply from 25 February 2021, will:
- introduce new definitions for personalized 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.
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