A raft of changes to the Canadian medical device regulatory landscape were seen in 2018, several of which were directed at harmonizing Canada’s approach to medical device regulation with those of other countries, increasing transparency and providing further guidance on issues affecting the use of software-based technologies in medical devices, including 3D printing and cybersecurity.
1. Health Canada’s action plan on medical devices
Health Canada released its action plan on medical devices (Action Plan), published in part in response to reports in Canada of serious adverse reactions caused by implantable medical devices—in particular, breast implants. The Action Plan sets out a three-part strategy to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients.
- To improve how devices get on the market. Health care professionals and researchers would be able to file applications for authorization to conduct investigational tests, and a new expert advisory committee on women’s health issues for drugs and medical devices would complement the existing two scientific advisory committees dedicated to medical devices (one on digital health and the other on cardiovascular devices such as pacemakers).
- To strengthen monitoring and follow-up. Health Canada currently requires mandatory reporting of medical device incident reports by manufacturers and importers and encourages reporting from healthcare practitioners, hospitals and patients/consumers. The Action Plan proposes to implement mandatory reporting of medical device incidents at hospitals. Health Canada would be able to compel medical device manufacturers to conduct assessments, tests and studies, and inform Health Canada within 72 hours of any risks or warnings published by foreign regulators.
- To provide more information to Canadians. The Action Plan proposes publishing certain clinical study data provided in medical device submissions and publishing its summaries of approvals to include Class III medical devices, as well as Class IV medical devices. Health Canada is also proposing to launch an accessible public database that contains medical device incident reports in a user-friendly, searchable, online format.
The three-part strategy is intended to strengthen processes for the pre-market approvals of medical devices, to provide a unified medical device registry, with a fulsome incident database (containing individual incident reports on post-market medical devices).
Various parts of the Action Plan are expected to be implemented in 2019, with continued engagement of Canadians through open communication and consultation on specific projects. Medical device manufacturers will want to monitor the progress of the Action Plan to assess which proposals are ultimately adopted and implemented.
2. Updates on Software as a Medical Device (SaMD)
Canada’s Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) held a meeting in January 2018 to discuss the regulatory approach for SaMD. Health Canada took SAP-SaMD’s comments into account in releasing a draft SaMD Guidance Document for external consultation with medical device manufacturers, importers, distributors, healthcare professionals, and other stakeholders.
The draft guidance document on SaMD considers software to be a medical device when 1) it is intended to be used for one or more medical purposes as outlined in the definition of device in the Food and Drugs Act,1 and 2) it performs these purposes without being part of a hardware medical device (i.e., it is not necessary for a hardware medical device to achieve its intended medical purpose).
Further, based on the intended use of the software, the draft proposes SaMD products would be broadly branded into two categories: Clinical Decision Support Software (CDS) intended for health care providers, and Patient Decision Support Software (PDS) intended for patients and caregivers who are not health care providers. The draft guidance also proposes software that does not have a direct impact on the diagnosis, treatment, or management of an individual’s disease, disorder, abnormal physical state or symptoms would not be subject to the Medical Devices Regulations.
The draft guidance also contemplates that software determined to be a medical device must be classified as an active device,2 as it relies on a source of energy other than energy generated by the human body or gravity.
Once the consultation period ends on March 29, 2019, it is expected that Health Canada will gather all input to finalize the draft guidance document.
3. Medical Device Single Audit Program (MDSAP) transition
Medical device manufacturers of Canadian Class II, III and IV medical devices are required to hold a Quality Management System (QMS) certificate, satisfying quality management system requirement ISO 13485. Previously, medical device manufacturers could comply with this regulatory requirement by receiving certification under the Canadian Medical Devices Conformity Assessment System (CMDCAS) program; however, as of January 1, 2019, Health Canada will only accept MDSAP certificates.
By way of background, on January 1, 2017, Health Canada implemented a two-year transition period, whereby the CMDCAS program would be replaced by the Medical Device Single Audit Program (MDSAP), designed and developed so that a single audit conducted by a MDSAP authorized Auditing Organization (AO) would meet the QMS requirements of multiple worldwide regulatory authorities participating in the program, derived from the ISO 13485:2003. During the two-year transition period, Health Canada accepted certificates issued both under CMDCAS and MDSAP.
In April 2018, Health Canada announced modifications to the transition process to assist medical devices manufacturers in moving to MDSAP. Specifically, in response to manufacturers experiencing difficulties in scheduling MDSAP audits with an AO in 2018, Health Canada indicated it would not take enforcement action against any manufacturers that could demonstrate they had undergone an MDSAP audit in 2018, but had not received a MDSAP certificate by December 31, 2018. In addition, manufacturers who underwent an initial recertification audit to ISO 13485 under CMDCAS on or after January 1, 2016 could transition into the MDSAP during the surveillance audit process, allowing them to maintain their existing certification cycles. Manufacturers who would have otherwise been unable to transition before December 31, 2018 now have options to continue selling their medical device(s) until they receive a MDSAP certificate.
4. Pre-submission meetings
In November 2018, Health Canada launched a pilot programmed called Device Advice: Pre-Clinical Meetings providing medical device manufacturers with opportunities to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. This pilot project was developed as part of ongoing Health Canada initiatives to increase efficiencies and support timely access to therapeutic products.
Select manufacturers were invited to participate in the pilot project, which will continue until March 2019. The pilot project is expected to result in the development of a new guidance document for Pre-Clinical Meetings including defined processes, timelines and information required to request such meetings.
5. GMDN—Health Canada exchanging information with other regulators
Health Canada has announced it will transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN). The GMDN is a list of generic names used as an internationally standardized device identification for international regulatory authorities to regulate medical devices. Health Canada’s adoption of the GMDN is expected to facilitate information exchange between regulatory authorities in various jurisdictions, and between Health Canada and health care providers, manufacturers and Canadians.
In 2018, Health Canada invited medical device manufacturers to propose GMDN codes for each of their licensed devices. Health Canada is currently in the process of reviewing the GMDN codes assigned by the manufacturers, which will then be published in the Medical Device Active Licence Listing. Medical device licence application and licence amendment forms will also be updated to require submission of the GMDN code for the medical device.
6. Case law on medical devices
2018 saw six court decisions in Canada relating to medical device product liability claims.3 While not all of the court decisions directly addressed the substantive issues on the product liability claims, these cases demonstrate that product liability claims and class action claims continue to be an area of risk for medical device manufacturers. Media has also been heightening awareness that patients harmed by medical devices can consider litigation as an option.
7. Update on transparency laws
By way of background, on December 12, 2017, the Ontario government enacted the Health Sector Payment Transparency Act (HSPTA),4 which has not yet been proclaimed into force. On February 21, 2018 the Ontario government released the proposed regulation under the HSPTA, known colloquially by some as Ontario’s “sunshine” legislation. The HSPTA is intended to strengthen transparency of financial relationships within Ontario’s health care system and increase public trust and confidence. Should the law come into force, the legislation is expected to require that the medical industry, including medical device companies, report annually to the Minister of Health and Long-Term Care on transfers of value provided to certain recipient individuals, including health care professionals, and organizations in the health care sector. The proposed regulation provides details on the categories of individuals and organizations that would be classified as “recipients” under the HSPTA; what would constitute a “transfer of value”; establishes exemptions to the reporting requirements; and set the value threshold for the reporting requirement.
The HSPTA and its regulation were originally expected to come into force on January 1, 2019, but the implementation has been delayed by the new Ontario government (elected in June 2018), and the future status is not known. If implemented, the HSPTA would be the first legislation of its kind in Canada and may serve as the benchmark for transparency laws in other Canadian provinces and territories.
Health Canada considers cybersecurity vulnerabilities in medical devices as a potential risk to patients, that manufacturers of medical devices must mitigate or eliminate. As part of Health Canada’s initiative to establish a revised regulatory approach for the emergent digital health technology sector, Health Canada published a draft guidance document on pre-market requirements for medical device cybersecurity for consultation in December.
The draft guidance provides medical device manufacturers direction on strategies to address the cybersecurity risk of all classes of medical devices that run software code.
- Secure design: Consideration of cybersecurity early in the product life-cycle when design requirements are being developed, including cybersecurity risks and controls when making design choices, and design choices that maximize device cybersecurity while not unduly affecting other safety-related aspects of the medical device (e.g., usability).
- Risk management: Incorporation of medical device cybersecurity into medical device’s risk management process, development and maintenance of an organizational framework for managing cybersecurity risks.
- Verification and validation test: All cybersecurity risk control measures must be successfully verified and validated against design specifications and/or design requirements, and testing should include verification and validation of the functions, features and design elements that have been implemented to mitigate identified cybersecurity hazards.
- Monitoring and response to emerging risks and threats: Manufacturers must proactively monitor, identify and address vulnerabilities and exploits as part of their post-market management as cybersecurity risks to medical devise are continuously evolving.
In addition, the draft material specifies information that manufacturers would need to submit as part of a medical device licence application or an amendment application to demonstrate that its medical device (consisting of or containing software) is sufficiently secure from intentional or unintentional unauthorized access. All input gathered from the consultation process will be used to finalize the draft guidance document, which is expected to be published in 2019.
9. Implantable devices and 3D printing
In October 2018, Health Canada published for consultation a draft guidance document on licensing requirements for implantable medical devices manufactured by 3D printing. The draft guidance is intended to assist manufacturers seeking to licence 3D-printed medical devices. Specifically, the draft guidance document specifies the evidence required to support pre-market Class III and Class IV licence applications for implantable medical devices manufactured by 3D printing processes under ISO 13485. Pursuant to the draft guidance document, licensing applications for medical devices manufactured by 3D printing would be required to include the following things.
- A device description, including the starting material, a description of the 3D printing method (e.g., laser sintering, direct metal laser sintering, powder bed fusion etc.), an overview of the manufacturing process and other information on the design philosophy and marketing history of comparable 3D-components if relevant.
- Safety and effectiveness information including, for example, a list of standards, preclinical, animal and clinical studies, considerations related to post-processing and sterilization, validation of the printing process and device performance, shelf life studies for the product, software verification and validation, and biocompatibility tests.
- Device labels, package labelling and documentation to ensure adequate device identification and design versions, while considering patient privacy and confidentiality.
All input gathered from the consultation process will be used to finalize the draft guidance document, which is expected in 2019.
10. Medical devices and cannabis
Before the coming into force of the Cannabis Act and Regulations on October 17,5 Health Canada published guidance documents on the regulation of health products containing cannabis or for use with cannabis, such as medical devices marketed with health claims which are subject to a premarket authorization by Health Canada.
Under the guidance, Health Canada contemplated that medical devices containing cannabis or for use with cannabis would include:
- medical devices used for the delivery of an associated prescription drug containing cannabis;
- single integrated prescription drug-device combination products;
- medical devices with claims for use in consuming cannabis for medical purposes; and
- certain test kits that are in-vitro diagnostic devices used in laboratories for identifying cannabis in patient samples.
Notably, medical devices containing cannabis or for use with cannabis would be subject to dual licensing regimes under the Cannabis Regulations, and the Food and Drugs Regulations6 or the Cannabis Regulations and the Medical Devices Regulations, including pre-market license approval for Class II-IV medical devices.
However, as the Cannabis Act and Regulations are still new, it remains unclear how products would appropriately comply concurrently with the Cannabis Regulations and Medical Device Regulations. For example, manufacturers of such prospective products would need to assess how health claims could be presented in view of restrictions on permissible labelling and promotion under the Cannabis Act and Regulations. Guidance documents, enforcement and laws continue to evolve in this area.
Date: May 28, 2019
Source: Torys LLP