Question Period Note: Safety and Effectiveness of Medical Devices in Canada

Since the December 2018 release of the Medical Devices Action Plan, Health Canada has made significant progress on strengthening the regulation of medical devices in Canada.

• What is the Government doing to protect Canadians’ health and safety with respect to medical devices?

• The health and safety of Canadians is our top priority, which is why Canadians can be assured that medical devices licensed in Canada meet strict standards for safety and effectiveness.

• Since the launch of the Medical Devices Action Plan in December 2018, Health Canada has made significant strides to further strengthen the regulation of medical devices in Canada.

• Health Canada has enhanced engagement with its partners, and has launched a Scientific Advisory Committee on Health Products for Women, to hear from patient advocates, physicians and researchers on issues relating to women’s health and the regulation of the medical devices and drugs that they use.

• New regulations require hospitals to report safety issues with medical devices to help Health Canada quickly identify and take even more timely action on safety risks.

IF PRESSED… on the Medical Devices Action Plan

• Through this Action Plan, Health Canada has introduced policies and regulations that serve to:
o enhance the safety, effectiveness and quality of licensed medical devices;
o strengthen monitoring and follow-up by increasing oversight of medical devices;
o provide Canadians with better access to information about the medical devices they use.

IF PRESSED… on improving how devices get on the market

• Health Canada is examining the information it receives in support of medical device applications to ensure they continue to meet the highest standards of safety and effectiveness. The Department is also strengthening the way clinical trials involving medical devices are conducted in Canada.

• The Department continues to engage with experts patient groups to better understand health issues, risks associated with specific medical devices and the impact of new and innovative technologies.

• Health Canada implemented the Medical Device Single Audit Program (MDSAP) to strengthen our oversight of the
manufacturing quality of medical devices.

IF PRESSED… on monitoring and follow-up of medical devices

• Health Canada has improved the reporting of medical devices incidents, which helps the Department quickly identify and take even more timely action on safety risks.

• The Department has introduced new regulations that require hospitals to report safety issues with medical devices

• Health Canada has also increased its inspection capacity

IF PRESSED… on transparency

• Health Canada is committed to increasing openness and transparency about the health products that it regulates.

• Health Canada has launched a new Clinical Information Portal where Canadians can request clinical information on medical devices already on the market.

• Health Canada also launched a searchable online medical device incident database that contains information about medical device incident reports and recalls.

• Health Canada has provided open access to medical device inspection results to enable Canadians to have a greater understanding of how and why regulatory decisions are made

• Manufacturers of all medical devices must comply with the safety, effectiveness and quality requirements of the Medical Devices Regulations (Regulations) in order to sell their devices in Canada.

• Class II, III and IV medical devices must have a Medical Device Licence before they can be sold. Class I devices present the lowest potential risk (e.g. a wheelchair) and Class IV devices present the greatest potential risk (e.g. pacemakers).

• When a company wishes to market a Class II, III or IV medical device in Canada, it submits a medical device licence application with a copy of their quality system certificate. The amount of information required increases depending on the class of the device.

• Health Canada also issues medical device establishment licences (MDELs) for the activities of importing and distributing Class I-IV medical devices in Canada, as well as manufacturing Class I medical devices for sale in Canada. The Department inspects these establishments to make sure they are in compliance with applicable regulatory requirements.

• The Department’s programs take a consistent approach to post-approval safety surveillance, assessment of signals and safety trends, and risk communications regarding all regulated marketed health products. Health Canada utilizes safety information obtained from different sources. Systematic scanning of information enables the Department to keep abreast of global health product issues and contributes to coordinated and consistent post-market medical device surveillance. Assessments of potential safety issues are conducted and risk mitigation recommendations are made based on critical analysis of all the available scientific and clinical data.

• Health Canada takes the need to understand what impact product suspension or removal could have on impacted patients very seriously. It is important to understand medical needs and therapeutic options of current and future patients before taking regulatory action.

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