Forward Regulatory Plan 2019-2021: Regulations amending Certain Regulations Under the Food and Drugs Act (Post-Market Surveillance of Medical Devices)

Title of Regulatory Initiative

Regulations amending Certain Regulations Under the Food and Drugs Act (Post-Market Surveillance of Medical Devices)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to amend the Medical Devices Regulations (MDR) to strengthen the post-market surveillance and risk management of medical devices in Canada.

This proposal includes bringing in regulations to support the life cycle amendments of Vanessa’s Law for medical devices. It also includes adding an information request tool to assess the safety of a device and implementing a periodic proactive surveillance reporting requirement for medical device manufacturers. A minor change supporting the principles of harmonization is being made to Part 1 (General).

Providing additional oversight on medical devices already in use would help promote safety and effectiveness for medical devices.

Regulatory cooperation efforts (domestic and international)

These regulations are not subject to a regulatory cooperation work plan with provincial, territorial or foreign regulatory partners. Some of the proposed regulations were modelled after European or American regulations, such as annual summary reports or the requirement to submit tests and studies.

Potential impacts on Canadians, including businesses

This regulatory initiative is expected to bring benefits to Canadians as Health Canada would be able to provide more accurate and timely information to Canadian patients regarding the risks and benefits of medical devices.

There would be an impact on the medical device industry. This regulatory initiative would place increased requirements on industry, including reporting requirements. However, industry would benefit from increased clarity on what to report and when.  

There are no significant impacts expected on international trade or investment.

Consultations

A Notice of Intent (NOI) was published on April 10, 2018, and sent directly to Canadian and foreign medical device manufacturers and medical device establishment licence holders.

Presentations to industry regarding the proposed life cycle amendments and proactive surveillance requirements were made between the months of May and July 2018. Health Canada also engaged in a targeted information session in November of 2018.

A webinar was held on January 15, 2019 to seek stakeholder input on a survey to assist in the development of a cost-benefit analysis.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2019 and last 70 days.

Further information

Draft guidance documents will be published on the Government of Canada website.

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email address: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

October 1, 2018

Consult Health Canada’s acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada’s implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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