Australia Issues Draft Guidance on Regulatory Scheme for Personalized Devices

Australia’s Therapeutic Goods Administration is seeking feedback from devicemakers on how personalized devices should be regulated.

The guidance defines personalized medical devices as those devices that are manufactured for a particular patient, including 3D-printed devices. These devices are currently covered under the custom-made medical device definition.

In a November 2017 consultation paper, the TGA noted the increasing use of 3D printing for medical applications was raising concerns about the adequacy of the current regulatory framework to mitigate risks to patients and to meet requirements for health care providers and manufacturers.

Stakeholders said the TGA needed to improve the existing regulations for custom-made device regulations because they are too broad (IDDM, June 4, 2018).

The current regulations “can result in some significant risks for patients receiving high risk custom-made devices such as permanent implants,” because they don’t have the same level of regulatory oversight as similar conventionally manufactured devices, the TGA said.

The proposed changes would allow the TGA to enter and inspect custom-made device manufacturing sites, and sponsors of overseas-manufactured custom-made devices would need to provide annual reports to the agency about the devices they supplied.

Documentation about implantable custom-made devices would need to be retained for at least 15 years compared to the current five-year retention. In addition, a manufacturer’s statement about a custom-made device would have to be provided to the patient receiving the device.

The TGA’s guidance proposes adopting the International Medical Device Regulators Forum definitions that would result in personalized medical devices being grouped into three categories:

• Custom-made medical devices;
• Patient-matched medical devices; and
• Adaptable medical devices.

Medical devices that fit the harmonized definition of custom-made, which is more detailed than the current Australian definition, would still be eligible for the exempt status, with limited regulatory oversight.

The patient-matched category of devices, which currently falls under the custom-made definition in Australia, would no longer be eligible for this exemption, and instead would require third party regulatory oversight.

The TGA plans on introducing a framework for regulating medical device production systems that allow providers to produce lower-risk personalized devices for treating their patients without the need for manufacturing certification.

Read the guidance here: www.fdanews.com/02-28-19-TGAguidance.pdf.