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 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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A near miss is an accident that’s waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.