Consultation on Proposed Regulations Amending the Medical Devices Regulations (Post-market Surveillance)

From Health Canada

You are invited to provide your input on the proposed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices), which have been pre-published in Canada Gazette, Part I. The feedback provided during this consultation will be taken into consideration prior to the regulations being finalized and published in Canada Gazette, Part II.

For the purpose of the proposed new section 61.2 which requires the reporting of actions which occur in specified foreign jurisdictions, we have included a list of foreign regulatory agencies. This list is proposed to be incorporated by reference into the proposed regulations.

Who should participate in the consultation

This consultation is open to all Canadians, and everyone is invited to share their ideas.

In addition, we would like to hear from:

• Medical device manufacturers and importers
• Patients and patient groups

Related information

• The Food and Drugs Act
• The Medical Devices Regulations
• Notice of Intent
• Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality

How to participate

You are invited to review the proposed regulations which have been pre-published in Canada Gazette, Part I, and the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations and to provide us with your comments in following ways:

Email: hc.lrm.consultations-mlr.sc@canada.ca

Mail:
Office of Legislative and Regulatory Modernization
Health Products and Food Branch
Health Canada
Address Locator: 3000A, 11 Holland Avenue, Suite 14,
Ottawa, Ontario
K1A 0K9

Supporting document

An accompanying draft guidance document has been prepared to provide stakeholders with additional information to help them provide their feedback on the draft regulations. The document includes an explanation of key elements of the proposed regulations, as well as initial guidance from Health Canada on its interpretation of the regulations and what would be required to comply. Therefore, it should be read together with the proposed regulations.

Feedback received on or before August 26, 2019, will be considered when we revise this draft guidance document.

You may submit your comments and ideas about the draft guidance document to:

Office of Policy, Risk Advisory and Advertising
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9

Email: MHPD-DPSC.VL-LV@hc-sc.gc.ca