New Health Canada Requirements to Improve Medical Products' Safety

The new requirements will direct manufacturers to, if requested, assess the safety of their products and do further safety testing when issues are identified, and also prepare annual summary reports of all known adverse effects, reported problems, incidents, and risks.

Ginette Petitpas Taylor, Canada's minister of health, recently announced new requirements for manufacturers of medical devices such as insulin pumps and pacemakers that are vital to the health and well-being of many Canadians. Canadians can comment on the proposed changes to regulations until Aug. 26 by visiting this website.

The new requirements will direct manufacturers to:

  • if requested, assess the safety of their products and do further safety testing when issues are identified
  • if requested, provide an analysis of the safety and effectiveness of their product so Health Canada can conduct a post-market safety review
  • prepare annual summary reports of all known adverse effects, reported problems, incidents, and risks
  • notify Health Canada if there has been a change to the risks or benefits

The new requirements also would help Health Canada better understand the risks and benefits of marketed medical devices. As part of its Action Plan on Medical Devices launched in December 2018, Health Canada committed to strengthening its monitoring and follow-up of medical devices already on the market, and the new regulatory proposal is a key part of that plan.

"Canadians rely on medical devices to maintain and improve their health. Last fall, I committed to Canadians that we would take action to improve the safety of these devices. This consultation is an important part of that commitment. These proposed changes would make it easier for Health Canada to monitor the safety of medical devices already on the market and to take action to protect the health and safety of Canadians," Taylor said.

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