Current Regulation of Software as Medical Devices in Canada
Medical devices in Canada are regulated federally by Health Canada's Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada's Food and Drugs Act (Act) and Medical Device Regulations (Regulations). In Canada, a medical device includes an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms.1 Medical devices are categorized into four classes determined by applying the classification rules for medical devices detailed in Schedule 1 of the Regulations.2 Class I represents the lowest perceived risk, and Class IV represents the highest perceived risk.
Software that has a medical application can be regulated as a medical device in Canada, and Canada's Medical Devices Bureau classifies software on the basis of its functionality and risk. Although medical device software is most typically assigned a Class I or Class II rating, it can receive a higher classification based on the Canadian classification rules for medical devices. These classification rules consider several factors including degree of invasiveness in the body, duration of contact, body system affected, and local versus systemic effects.3
For example, based on current Canadian classification rules, software intended for analysis of data that directly aids physicians in the treatment or diagnosis of a patient would most likely be classified as a Class II device.4 However, such device could be classified as a Class III device if an erroneous reading by the software could result in immediate danger to the patient.5 On the other hand, software that only transmits or stores data would most typically be classified as a Class I device. For example, software used to transmit data received from blood pressure monitors and blood glucose monitors would likely be a Class II device if it analyzed the data for the purpose of directly aiding in the treatment or diagnosis of the patient.6
Canada's current classification rules for medical devices can arguably be difficult to navigate when considering the appropriate regulation of software as a medical device, particularly since the rules were drafted before the age of mobile medical apps on smartphones and tablets. Like many industries, the health care industry has become progressively more reliant on software. Canada's classification rules for medical devices must therefore be flexible and/or sufficiently robust to account for these technological advances, to inform device stakeholders, and to ensure that safe and effective products can be marketed in a timely manner.
Health Canada's Developing Approach to Digital Health Technologies
In 2018, Health Canada has undertaken a multifaceted initiative to establish a revised regulatory approach for the emergent digital health technology sector, while ensuring safety and effectiveness of medical devices. One of Health Canada's key areas of focus is the regulation of Software as a Medical Device (SaMD). As stated in Health Canada's April 10 notice regarding the digital health initiative, "[d]igital health technology can include stand-alone software applications as well as integrated hardware and software systems which can utilize platforms, such as computers, smart phones, tablets and wearables."7 Some examples include wireless medical devices, mobile medical apps, telemedicine, software as a medical device, artificial intelligence, cybersecurity, and medical device interoperability. A Scientific Advisory Committee on Digital Health Technologies (SAC-DHT) has also been announced by Health Canada for fall 2018.8
As part of the initiative, Health Canada has proposed to establish a new Digital Health Review Division within the Therapeutic Products Directorate's Medical Devices Bureau. This is to allow for a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health, and to respond to fast innovation cycles. Health Canada has also committed to the ongoing re-evaluation of business processes.9
Also, on January 26, Health Canada convened a Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) to provide timely scientific, technical, and medical advice on current and emerging issues related to SaMD.10 The SAP-SaMD's mandate has focused on two main issues: (i) the definition of SaMD and the scope of medical devices; and (ii) the preliminary draft guidance document (Draft SaMD Guidance Document) intended to provide a definition of SaMD, and to provide guidance on classification of SaMD as per the Regulations.11 Questions considered by Health Canada's SAP-SaMD are (i) whether the classification rules that exist in the regulations are sufficient to classify the risk of current software as medical devices; and (ii) are improved processes required for timely access to medical device software that has short development cycles.12
Health Canada is expected to take SAP-SaMD's comments into account prior to releasing the draft SaMD Guidance Document for external consultation with medical device manufacturers, importers, distributors, healthcare professionals, and other stakeholders who need assistance in understanding which products qualify as a SaMD, as well as how SaMD is classified. It is expected there will be an opportunity for stakeholders to comment on the draft Guidance Document before it is finalized.
Global Harmonization of Digital Health Regulation
Health Canada's developing approach to digital health technologies follows recent digital health reform announcements by other global regulators including the United States Food and Drug Administration's Digital Health Innovation Action Plan13 and the European Parliament and Council's adoption of the Medical Devices Regulation (MDR),14 and In Vitro Diagnostic Medical Devices Regulation (IVDMDR).15 Possible approaches to classification of software as medical devices could include classifying software, which drives, controls or influences the use of a device within the same class as the device; but classifying software in its own right if that software is independent of any other device.
In certain publications to date, Health Canada has used the definition of SaMD provided by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world that work to create a convergent and harmonized global regulatory framework for medical devices. Therefore, as the Canadian approach continues to evolve, it will be interesting to see which, if any, of the IMDRF's recommendations and interpretations Health Canada chooses to adopt.
What Happens in the Meantime?
In the period before the draft SaMD Guidance is finalized, Health Canada is likely to continue to apply its publications titled "Software Regulated as a Class I or Class II Medical Device"16 and "Software Regulated as a Medical Device — Frequently Asked Questions."17
What to Expect in the Coming Months
It is expected Health Canada will release the draft Guidance Document on SaMD for external consultation in 2018 or 2019. Along with the establishment of the new Digital Health Review Division, regulatory reform is underway in Canada. Globally, regulatory reform of software regulated as a medical device and digital health technologies is on the horizon for many other countries, and stakeholders will be closely monitoring developments in Canada to assess how the regulatory language will evolve.
This article first appeared in Digital Health Legal.
Footnotes
1 Food and Drugs Act ( R.S.C. , 1985, c. F-27); see definition of "device" for full definition.
2 Regulations, Schedule 1.
4 Ibid, Schedule 1, Rule 10(1).
5 Ibid, Schedule 1, Rule 10(2). It provides that "a device described in subrule (1) that is intended to be used to monitor, assess or diagnose a disease, a disorder, an abnormal physical state or a pregnancy, if erroneous readings could result in immediate danger, is classified as Class III."
9 Health Canada, Building better access to digital health technologies, April 9, 2018. https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/building-better-access-digital-health-technologies.html.
13 US FDA, Digital Health Innovation Action Plan, < https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf>.
14 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. [MDR].
15 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. [IVDMDR].
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