Canada may not be one of the larger medical device markets on the global scene, but its regulatory structure is quite substantial. Its medical industry, consisting of mainly small to medium-sized organizations, is rooted in a solid regulatory foundation that has matured over time. While their first medical device structure was implemented under Canada’s Food and Drugs Act (Act) in 1975, the introduction of a risk-based classification system for devices wasn’t put into place until 1998. The main drivers behind this change were the increasing pressures of global regulatory harmonization and ever-evolving technologies. Prior to the 1998 Amendment, most devices were not under scrutiny of a premarket review and for those that were, risks associated with the changing technologies were easily identified.
As global harmonization gained momentum, Canada was forced to adapt its regulatory structure. The Global Harmonization Task Force (GHTF) was born in 1992 and included Australia, Brazil, Canada, European Union, and Japan as its founding members. The intent of this partnership was to foster the sharing of information, identify common issues, consider advancements in industry, and provide a common approach to oversight. Canada’s involvement provided a foundation for its own jurisdictional changes, as evident in its Medical Devices Regulations (SOR/98-282). Wanting to be in-step with their fellow jurisdictions and to avoid potential trade barriers, Canada used existing quality management system techniques (initially ISO 9001 and then ISO 13485) and internationally established regulatory requirements to bring their program into force. At that time, Australia and the EU had both well-defined risk-based device classification systems and in-depth product review systems (‘technical file’ reviews). From this came the four-tiered classification system used today. In addition, Canada leveraged its involvement with the GHTF to adopt the Summary Technical Documentation (STED) to address gaps in its premarket applications review process.
Effective January 1, 2003, Canada launched the Canadian Medical Devices Conformity Assessment System (CMDCAS). Co-developed by the Standards Council of Canada (SCC) and Health Canada’s Therapeutic Products Directorate (TPD), it was designed to implement the Medical Devices Regulations which require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under a registered quality management system (QMS) such as ISO 13485.
Health Canada required medical device manufacturers to use the quality system certificate as evidence of compliance to the appropriate regulatory quality system requirements through the application of medical device licenses required for sales. Under the CMDCAS, Health Canada would only accept a quality system certificate (ISO 13485) that has been issued by special third-party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. These third-party organizations, who also happened to be certification bodies, were recognized following the effective completion of training and competency evaluations.
Canada also moved further with its direct involvement with the US FDA in a collaborative regulatory effort. The 2003 Memorandum of Understanding between the US Food and Drug Administration (FDA) and the Health Products and Food Branch of Health Canada (HC) and 2005 broader government-level Security and Prosperity Partnership (SPP), paved the way for the 2006 Pilot Multipurpose Audit Program (PMAP). Recognizing the benefits of closer regulatory cooperation, both countries acknowledged the importance of the role of third parties in the oversight of the medical device industry. The outcome was that qualified auditing organizations (AOs) would perform third-party audits/inspections of medical device manufacturers’ quality systems that will respectively meet the regulatory requirements of the US and Canada. This model of multipurpose audits/inspections was already taking place under other programs, so it had a proven track record, as evident in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices Conformity Assessment System (CMDCAS). The PMAP was intended to strengthen regulatory cooperation and reduce the burden on industry by having one audit of medical device manufacturer that would be shared between both regulatory jurisdictions. In doing so, the FDA, if accepting the information, would remove the manufacturer from its annual work plan in exchange for their participation in the PMAP. While sounding both practical and a cost-savings for both the manufacturers and regulators, companies were taking a risk that issues that might be uncovered during the audit would be shared with the FDA that might not have been available to them otherwise due to the fact that, other than in the US, there is no legal requirement to disclose such information as there is under the US’s Freedom of Information (FOI) Act. The FDA continued to maintain the right to audit the manufacturer on their own, even after the third-party had done so. This had a considerable effect on the rate of participation in the program.
Following this in 2011, Canada once again stood with its jurisdictional colleagues during the formation of the International Medical Device Regulators Forum (IMDRF). Canada’s continued presence helps to influence the acceleration of international medical device regulatory harmonization and convergence.
Canada’s regulatory efforts are also seen in their participation with the Medical Device Single Review Program (MDSRP), conducted in the Canada-United States Regulatory Cooperation Council to harmonize premarket technical review requirements for moderate risk medical devices, and the eSTAR program which is designed to assist applicants through the device submission process. Canada has also participated in IMDRF working groups for the development of cybersecurity guidance and Software as a Medical Device (SaMD).
In January 2019, as Canada continued its regulatory collaboration with global jurisdictions, Canada transitioned from the CMDCAS program to the Medical Devic Single Audit Program (MDSAP) as it joined the alliance with Australia, Brazil, Japan, and the United States. This meant that any manufacturer wishing to sell medical devices into Canada would be required to be certified under the MDSAP. This was risky for Canada to require, as the other jurisdictions did not, and while it did cost Canada the loss of some manufacturers marketing products in their country, it was also instrumental in the success of the MDSAP. One could argue that Canada put the ‘teeth’ into the program.
Canada has also been focused on emerging technologies in its quest to promote regulatory compliance. Their work in the IMDRF produced a guidance document on medical device cybersecurity in 2020 and through a partnership with both the US FDA and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), a 2021 digital health guidance document on good machine learning practice for medical device development was published. Today, Health Canada also cochairs IMDRF’s Software as a Medical Device (SaMD) Working Group.
Technological advances in medical devices result in more complex health products and the possibility that existing regulatory frameworks may not be suited to address this innovation. Recognizing this, in a step forward for regulatory compliance, Canada amended its Food and Drugs Act in June 2019 by creating a new regulatory pathway to accommodate the unique characteristics of these newly coined advanced therapeutic products (ATPs), an example of which is adaptive machine learning-enabled medical devices (MLMD). The new framework allows the customization of requirements to provide a flexible regulatory oversight that promotes innovation in product development and reduces barriers to introduce ATPs in Canada, while ensuring rigorous standards of safety and product quality, efficacy, and effectiveness.
Canada also sought to address its post-market regulation which had been somewhat stagnant. In 2014, it amended its Food and Drugs Act to enact the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), strengthening its ability to collect post-market safety information changing focus from a reactive to a more proactive approach to regulation, using real-world evidence and aligning its approach with other jurisdictions such as the EU and its Medical Device Regulation (EU MDR) requirement for a periodic safety update report (PSUR), which can be tailored to be specific to devices on the Canadian market.
Lastly, in a shift in thinking, Canada, which once felt that transparency of therapeutic product oversight should be kept confidential, has now developed new regulations to provide public access to some clinical information. This new thinking is aligned with the European Medicines Agency (EMA)’s approach, but in contrast with that of the FDA, due to FOI.
As a result of all factors noted above, Canada’s shift in its regulatory structure and direction has been considerable and exemplary with respect to the global market demands. Canada joins other jurisdictions in their concern over the rapid pace of technology, better harmonization for regulating emerging technologies has brought together global regulators, and increased development and use of post-market information for the safeguarding of the public.
