Medical Devices Action Plan: Progress report

This update shows you the progress we have made on the Medical Devices Action Plan (MDAP), and points to areas where we will continue to deliver results to Canadians.

On this page

• Medical Device Action Plan purpose and progress
• Improve the safety and effectiveness of medical devices and how they get to the Canadian market
• Strengthen the monitoring and follow-up of medical devices used by Canadians
• Provide more information to Canadians about the medical devices they use
• Conclusion and next steps

Medical Device Action Plan (MDAP) purpose and progress

We launched the MDAP in December 2018. Since its publication, we have made significant progress toward achieving the goals of the action plan's 3 pillars. While we focused on the COVID-19 pandemic in 2020, we have continued to move forward and incorporate the action plan's principles into our work.

In 2020, we approved or authorised:

• 545 COVID-19 medical devices and 18 clinical trials for medical devices related to COVID-19
• 332 new medical devices in the highest risk categories (Classes III and IV)
• 122 new investigational testing applications for medical devices
• 2,693 requests for special access to medical devices

We also created a stand-alone Medical Devices Directorate (MDD) in January 2020. This new directorate represents an innovation for Health Canada in that we have, for the first time, incorporated both pre-market work and post-market work within the same directorate. We did this in recognition of the fast pace of medical device development and the importance of regulating medical devices from a life cycle perspective. The creation of this new directorate will allow us to engage more effectively with patients, healthcare professionals and industry.

PART I - Improve the safety and effectiveness of medical devices and how they get to the Canadian market

Under this pillar, we are working to:

• increase research by medical professionals and increase patient protection
• review evidence requirements and expand scientific expertise

1. Increase research by medical professionals and increase patient protection

Milestones

• We published our initial plan for clinical trial modernization on our website. We also launched a public consultation in May 2021.
• What we heard report: We will publish a "What we heard report" after the spring 2021 consultation.

We have incorporated the goal of increasing research by medical professionals and increasing patient protections into a larger focus on modernizing clinical trial processes and regulations for health products. The proposed regulations would allow independent researchers and medical professionals to conduct clinical trials on medical devices. The regulations also propose to require those who conduct clinical trials to register them online and provide information publicly about the results of the trial.

In May 2021, we published a public consultation paper for stakeholder comment. We expect to publish draft regulations for comment the following year.

2. Review evidence requirements and expand scientific expertise

Milestones

• Call for members for the new Scientific Advisory Committee on Health Products for Women: The call for new members occurred in January and February 2019.
• Draft guidance document on evidence requirements: We will publish a draft document for comment in the summer of 2021.

In May 2019, the Scientific Advisory Committee on Health Products for Women (SAC-HPW) met for the first time. They met again in November 2019, October 2020 and February 2021. The committee had patient-focused discussions on medical devices, including surgical meshes and breast implants. The SAC-HPW is planning additional meetings in 2021.

The SAC-HPW is a great forum to help build awareness on sex and gender-based analysis plus (SGBA+) related issues within the scientific and regulatory communities. Following SAC-HPW recommendations, we are committed to applying an SGBA+ lens to the work we do and have already embarked on SGBA+ training for staff.

We also continue to seek advice from the Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System and the Scientific Advisory Committee on Digital Health Technologies. The next meetings for both of these scientific advisory committees are being planned for the spring of 2021.

We will post the Draft Guidance Document on Clinical Evidence Requirements in summer 2021 for public consultation.

PART II - Strengthen the monitoring and follow-up of medical devices used by Canadians

Under this pillar, we:

• implemented mandatory reporting and expanded the Canadian Medical Devices Sentinel
• established the ability to compel information on medical device safety and effectiveness and expanded use of real-world evidence
• enhanced capacity in inspection and enforcement

1. Implement mandatory reporting and expand the Canadian Medical Devices Sentinel

Milestones

• Publishing of mandatory reporting by hospitals regulations to report medical device incidents in Canada Gazette, Part II: We published the final regulations in June 2019.
• Launch of education program for other health care settings: We are exploring how best to reach additional health care settings.

In December 2019, we began requiring hospitals to report medical device incidents and serious adverse drug reactions. To support hospitals, we held over 250 outreach events, and created online educational modules. In 2020, hospitals submitted almost 3,500 medical device incidents to Health Canada. The reports submitted by hospitals are a valuable source of information for the monitoring of health products. Reports from various sources, including hospitals, help influence Health Canada's surveillance activities and subsequent safety reviews, advisories and recall actions on health products.

These new mandatory reporting by hospitals regulations have been essential during the COVID-19 pandemic. The information provided by hospitals about personal protective equipment (for example, medical masks) enabled us to assess risks promptly and take action.

We have not yet completed the expansion of the Canadian Medical Devices Sentinel Network to include long-term care facilities or private clinics. However, we are encouraging reporting of medical device incidents at existing CMDSNet sites with long-term care facilities and clinics. In January 2019, the Canadian Medical Devices Sentinel Network added an additional site in the territories, moving us closer to pan-Canadian representation.

2. Establish ability to compel information on medical device safety and effectiveness and expand use of real-world evidence

Milestones

• Publishing of post-market surveillance regulations in Canada Gazette, Part II: We published the final regulations in December 2020.
• Establish how we will use real-world evidence for regulatory decision-making: We published an initial report outlining Health Canada's plan in March 2019.

In December 2020, we published final regulations on the post-market surveillance of medical devices. These regulations gave Health Canada powers to request tests and studies and new assessments from manufacturers in light of new information. Manufacturers will also be required to inform Health Canada within 72 hours if there are new warnings abroad about serious risks related to their medical device. By having greater access to timely and relevant information, we will be able to act quickly on problem medical devices that may pose a serious risk to the health of Canadians.

We developed and published a Strategy to Optimize the Use of Real-World Evidence (RWE) across the Medical Device Lifecycle in Canada. This strategy outlines a starting point for how we will use RWE to support regulatory decisions for health products.

3. Enhance capacity in inspection and enforcement

Milestones

• Hiring of an additional 8 inspectors and 2 investigational analysts: The new inspectors and analysts were hired in March 2019.
• Increase in the number of foreign inspections from 80 to 95: We completed these new inspections throughout 2019 and into early 2020.
• Increase in compliance promotion activities: We undertook compliance promotion activities throughout 2019 and into early 2020.

The additional inspection capacity has allowed us to respond more quickly to medical device incidents and increase industry inspections by 10% compared to previous years. This increase in inspections strengthens the oversight of the supply chain to ensure the quality and safety of medical devices that enter the Canadian market. We post all medical device inspections online for Canadians who wish to see if a company has been compliant. We are also working on outreach and compliance promotion efforts to build better relationships with our stakeholders.

PART III. Provide more information to Canadians about the medical devices they use

Under this pillar, we:

• improved access to medical device clinical data
• increased the information on device approvals and published medical device incident data

1. Improve access to medical device clinical data

Milestones

• Publishing of final public release of clinical information regulations in Canada Gazette, Part II: We published the final regulations in March 2019.
• Launch of searchable public web portal: We launched the portal in May 2019.

In March 2019, we put in place regulations that allow the publication of clinical information for Class III and Class IV medical devices. Canadians can now review or download this information through a web portal. Providing public access to this information:

• enables independent analyses of data by health care professionals and researchers
• can offer a broader understanding of the benefits, harms and uncertainties of medical devices

2. Increase the information on device approvals and publish medical device incident data

Milestones

• Publishing of searchable medical device incident database: We are exploring options for database enhancements to improve its usability.
• Publishing of more regulatory decision summaries: We added summaries for additional regulatory decisions in January 2019 and December 2019

Since January 2019, we have published a searchable web page of medical device incidents that lets users view or download more than 160,000 device incidents from 1978 to the present. This gives patients firsthand information on new or unanticipated incidents that may be occurring with a device that they use.

In December 2019, we began publishing Regulatory Decision Summaries for amendments to Class III and IV medical device licences. You can find Regulatory Decision Summaries on the Drug and Health Product Register. For patients with implants, these new information sources will allow them to monitor any changes regarding their implant, including new warnings or safety amendments initiated by the manufacturer.

In January 2020, we published an improved Drug and Health Products Inspection Database where Canadians can go for clear and detailed information on medical device inspection results. The web pages provide plain-language explanations to help you understand the inspection process for medical devices.

For additional information, patients can also consult the annual Drug and Medical Device Highlights report, which includes information about potential safety issues, and an overview of accomplishments related to drugs and medical devices.

Conclusion and next steps

The MDAP led to opportunities to meet with various patient support groups. These meetings allowed patients to share their concerns and experiences related to medical devices, which in return helped us better inform our decisions. For example, we met with patient representatives who had received surgical mesh implants for the treatment of stress urinary incontinence and experienced major complications. This meeting led to a better understanding of their issues and to the improvement of our incident form based on the input from these women.

Building on the Medical Devices Action Plan and its 3 pillars, we will continue its work through the regulatory innovation agenda. In particular:

• Clinical Trial Modernization will create an environment that encourages and supports the conduct of innovative trials in Canada. While this initiative originally focused on medical devices only, we recognized that other health products could also benefit from a more modernized clinical trial framework. Therefore, we expanded this project to cover drugs, natural health products and foods for special dietary purposes in order to create a consistent approach for both researchers and patients. Modernization efforts will focus on enabling access to innovative treatments and providing Canadians with more opportunities to participate in a broader range of trials. We will achieve this through:
  • more flexible approaches to overseeing new trial types and designs
  • risk-based approaches to the oversight of trials and products within those trials
  • improved transparency of clinical trial information
• The proposed regulatory changes would also incorporate Good Clinical Practices into trials and ensure that patient participants have all of the information that they need to participate in a trial and make informed decisions. Canadians will have an opportunity to comment on this project through the public consultation that was launched in May 2021.
• The Advanced Therapeutic Products Pathway allows us to authorize innovative products that don't easily fit under our existing health product regulations in a flexible and risk-based manner. New authorities introduced in the Food and Drugs Act in 2019 let us develop tailored requirements for drugs and devices with complex and unique characteristics, such as devices enabled by AI and continuously learning algorithms. This approach, known as a "regulatory sandbox," helps enable market access for these products with rules and regulatory oversight that are appropriate for them. Regulating products in a sandbox requires consultation with those directly involved in the development and use of these products (for example, hospitals, start-ups, innovators) and other health system players (for example, international regulators, health technology assessors). Early alignment and coordination with these groups will support access and adoption. Once marketed, we will manage risks through regulatory tools, such as terms and conditions, which enable agility. We also envision a specialized concierge service to help innovators and industry navigate the new pathway. We have planned targeted stakeholder engagement in 2021 to inform the design and implementation of the new pathway and concierge service.
• Agile Licensing for Medical Devices will support the creation of more agile and flexible medical device regulations that will allow us to regulate medical devices throughout their life cycles more effectively. For example, we will adapt our licensing scheme to allow the use of agile tools, such as terms and conditions, which help with life cycle oversight. In certain circumstances, we will also allow the use of decisions made by trusted foreign regulators that could help address gaps in treatment options for Canadians. The proposal will help further ensure that we regulate devices in line with the level of risk they pose to the health of Canadians. It will also allow us to respond efficiently to changes in a medical device as real-world evidence about a product's risks and benefits emerges in the post-market experience. We intend to engage with key stakeholders in 2021 and 2022 as we develop this proposal.

Throughout these new activities, we will seek to collaborate with patients, industry and other healthcare system partners to deliver results that will improve the lives of Canadians.