Health Canada Seeks to Better Define Regulatory Requirements for SaMD

Regulatory NewsRegulatory News
| 30 January 2019 | By Ana Mulero 

Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD).

Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, which would have partly modeled certain SaMD policies on those previously developed by Australia’s Therapeutic Goods Administration (TGA).

The draft guidance indicates that Health Canada has pivoted away from using some TGA policies for in vitro diagnostic SaMD. The 15-page document makes certain references to US Food and Drug Administration (FDA) guidance documents related to SaMD, seeking alignment with FDA's exclusion criteria after these received modifications via the 21st Century Cures Act of 2016. With TGA’s December 2018 release of SaMD guidance, TGA signaled needed updates to Australia's classification regulations to better reflect SaMD risk. 

The draft guidance represents the agency’s response to the booming global digital health sector, which has resulted in a growing body of software products intended for patient and/or provider use. These policy clarifications were developed as Health Canada’s interpretations of the Food and Drugs Act regulations and of the five-year-old SaMD definition developed via the International Medical Device Regulators Forum (IMDRF).

The draft guidance clarifies that the “functionality of any software product and the manner in which it is represented or labeled for use, dictates whether it qualifies as a medical device under Health Canada’s regulations.”

The criteria described throughout the draft guidance are intended to serve as references for sponsors when making determinations on whether SaMD falls within the scope of Canada’s regulations and are thus subject to set regulatory requirements on medical devices based on risk classification. “Where feasible, the exclusion criteria were aligned with those from the United States FDA,” Health Canada said.

A separate document was created in conjunction with the draft guidance to provide examples on SaMD.
In terms of the level of regulation on SaMD, determinations on classifications would depend on both a manufacturer’s labeled intended use and the classification rules. A fundamental component of the process used to guide these determinations relates to intended use.

According to the draft guidance, SaMD intended use should address three main factors: the significance of a SaMD ‘s information on a clinical decision, state of the situation or condition it is intended for and core functionality. Health Canada said that most SaMD applications will be classified as Class II under Rule 10. This depends on whether SaMD’s intended use “stated that it would be used in a serious health care situation.” The “fall-back rule for active devices”—Rule 12—will apply to all other SaMD for their classification into Class I.

Health Canada seeks feedback until 29 March on the draft guidance, specifically as it relates to the proposed inclusion criteria, exclusion criteria, the framework for the classification of SaMD and examples of SaMD.

Draft guidance


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