Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.
According to TGA, the Australia's current regulations, which include exemptions from registration for custom-made devices, have not kept up with the pace of innovation in the custom device space.
"The provisions were based on the premise that affected devices would largely comprise low risk products such as glass eyes, prosthetic limbs, prescription lenses, etc. This assumption regarding risk classification was accurate at the time the current custom-made medical device provisions were introduced, but the situation has evolved," TGA writes.
Now, the agency says, advances in medical imaging and materials science have led to the development of more complex and higher risk personalized devices, such as patient-specific implantable devices, that would normally warrant strict regulatory oversight.
Under current Australian regulations, a custom-made medical device is one that:
- Is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
- Is intended:
- To be used only in relation to a particular individual; or
- To be used by the health professional to meet special needs arising in the course of his or her practice.
Devices that qualify as custom-made are exempt from registration in the Australian Register of Therapeutic Goods (ARGT), though they must still meet certain requirements for conformity assessment, including:
- Prepare a statement about the device and its compliance with the essential principles;
- Prepare documentation for the device in relation to its design production and intended performance;
- Ensure that the manufacturing process results in the device complying with its design and intended performance; and
- Notify the Secretary of adverse events or potential adverse events, or recalls of the device.
However, these requirements do not require any information to be provided to patients or interaction with TGA beyond adverse event reporting. Additionally, while TGA is able to request information from custom-made device manufacturers, the agency does not have authority to carry out inspections of their facilities.
TGA also notes that its custom-made device regulations do not cover mass produced 3D printed devices, as those would not meet the definition of a custom-made device, or products made from 3D printed human tissues, as such products would be regulated as biologics.
In the consultation document, TGA is proposing five potential changes to the current regulations governing custom-made devices.
First, TGA is proposing to introduce a new definition for custom-made medical devices similar to the one used by the US Food and Drug Administration for "patient-matched" devices that would exclude patient-specific devices modified from a standard template to match a patient's anatomy. Under that definition, 3D printed patient-specific devices would be regulated as regular medical devices based on their risk classification.
The new definition would also include a specific category for "medical device production system" which would cover 3D printer systems and raw materials used by healthcare practitioners to produce a finished medical device. This definition would allow doctors and hospitals to produce custom devices without needing to register as manufacturers.
The second change TGA is proposing is to alter the conformity assessment procedure for custom-made devices to require information about the device be provided to the patient, allow TGA to inspect facilities that make custom devices, manufacturers to submit an annual report on the devices they supplied and require manufacturers to retain documentation about custom implantable devices for 15 years.
Next, TGA is proposing to change the definition of a medical device manufacturer to clarify that producers of customized devices, such as hospitals, are not considered manufacturers. This would allow health care practitioners and hospitals to use approved medical device production systems to make low- to moderate-risk devices (Class IIa and lower) without needing to meet certification requirements as a manufacturer.
TGA is also proposing changes to its regulations for anatomical models to include the software and models themselves as Class IIa devices. Under TGA's proposal, manufacturers of such models would be required to meet the same requirements as traditional Class IIa devices, though such requirements would not apply to hospitals or healthcare providers using an approved medical device production system.
Lastly, TGA is proposing to begin regulating devices that contain a human tissue component, but not wholly made from human tissue, as Class III devices rather than as biologics. This would bring the country's regulations more in line with regulations in the US, EU and Canada.