TGA Clarifies SaMD Policies, Signals Changes to Classification Regulations

Regulatory NewsRegulatory News | 12 December 2018 |  By 

Australia’s Therapeutic Goods Administration (TGA) released new guidance on the regulation of software as a medical device (SaMD), with plans to change SaMD classification.
The guidance clarifies the types of software and mobile applications that fall within the scope of the SaMD regulation based on the definition of a medical device. These include “smart phone apps that calculate insulin doses based on a patient's blood glucose levels” and software that uses “information about a patient to make a diagnosis,” according to the guidance. Health and lifestyle apps and software that do not meet the medical device definition fall outside the scope.
TGA also offered several examples to describe how certain SaMD products are regulated. Apps and software solutions that are integral to the intended purpose of a physical medical device are not regulated separately. A mobile app that controls or adjust a medical device via Bluetooth or WiFi would be regulated at the same risk classification level as its medical device. 
Yet the risk-based approach under current regulations for classifying or reclassifying medical devices fails to adequately capture SaMD, according to TGA. “At the present time many SaMD products are classified as low risk even though the potential risk for users may be higher,” TGA said. The agency “will soon be consulting on changes to the regulations to address this issue.”
The SaMD categorization was developed in collaboration with other regulators via the International Medical Device Regulators Forum (IMDRF) about four years ago. TGA’s guidance points to this document and the four other SaMD documents established by IMDRF, which relate to clinical evaluations, key definitions and application of a quality management system.
TGA said it “recognizes that the existing regulatory framework for medical devices in Australia may not be well structured to address the potential public health risks posed by SaMD products.” The agency is now looking to harmonize with the published IMDRF technical documents as part of its ongoing review on the regulatory framework for SaMD in Australia.
Meanwhile, other IMDRF member agencies have also recently launched reviews of the existing regulatory frameworks in their own countries. These include the US Food and Drug Administration’s (FDA) push for a shift to be driven by its Pre-Certification (Pre-Cert) program. But Health Canada delayed releasing draft guidance for SaMD classification over concerns raised by a scientific advisory panel in October and it created a new Digital Health Review Division.
The efforts seek to keep pace with the iterative nature of digital health technologies while promoting innovation in the sector as it continues to grow globally.
Regulation of Software as a Medical Device


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