TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

Regulatory NewsRegulatory News | 13 February 2019 |  By 

Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to propose a regulatory framework for personalized devices, including 3D-printed devices.

The 19-page SaMD document expands on guidance TGA posted last December. The 23-page proposed regulatory scheme for personalized medical devices comes after the agency launched a consultation in 2017 to propose changes to Australia’s regulations for such products and subsequently delayed implementing any regulatory changes over concerns raised in submissions on that consultation in 2018.  

Both guidance documents are intended to advance proposed regulatory amendments for TGA’s regulation on software and on personalized devices. In addition to the 2017 consultation on personalized devices, TGA indicated in its SaMD guidance from last year that regulatory changes to the existing framework are needed to better reflect the risks associated with certain software technologies.

The new guidance on SaMD describes “three key issues” regarding the existing framework for the regulation of software in Australia. These relate to how classification rules “do not adequately consider the potential for SaMD products to cause harm to patients,” a lack of monitoring and accountability for software products that users can download directly from publishers, as well as a lack of clarity in regulatory requirements for demonstrating medical device software safety, quality and performance.

Similarly, the proposed regulatory changes are three-fold. They call for ensuring appropriate classifications of SaMD products according to the potential harm to patients, excluding SaMD products from personal importation provisions of Australian’s medical device regulations so that they are required to be registered with TGA and have an Australian sponsor and ensuring clear and transparent requirements for demonstrating safety and effectiveness are reflected in the essential principles.

“The proposed changes will, wherever possible, be harmonized with international best practice,” TGA noted. This is in line with the agency’s participation in the International Medical Device Regulators Forum (IMDRF), which developed a harmonized SaMD definition about five years ago in collaboration with other participating global regulators. TGA is also proposing to align the transition period for implementation of its SaMD proposed changes with the transition of EU’s medical device regulation (MDR). As such, both the SaMD regulatory changes and EU MDR will come into effect next year. This is consistent with a 2016 recommendation of the Australian government for harmonization.

TGA proposed six regulatory amendments under its scheme for personalized medical devices. These call for introducing new definitions, changing requirements on supplying custom-made medical devices in Australia to mandate additional information to TGA and patients and allow the agency to conduct manufacturing site inspections and establishing a framework for the regulation of a medical device production system

The proposed changes also relate to updates to the classification rule on devices that record diagnostic images to include all devices of this type, including 3D-printed anatomical models, regulating devices with a human origin component and changes to supplied devices as intended by original manufacturers.

The guidance comes after IMDRF finalized a 10-page technical document on definitions for such devices, including patient-specific and custom-made devices, last November. TGA chaired this IMDRF work item.


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