Dive Brief:

• Health Canada is seeking public comment on proposed rule changes intended to improve the safety and effectiveness of life-saving medical devices such as insulin pumps and pacemakers.
• The new regulations would require medical device manufacturers to provide Health Canada with safety information about devices once they are on the market.
• Canadians can comment on the proposed regulations until Aug. 26 at the Canada Gazette website.

Dive Insight:

The amendments would extend to medical devices provisions of the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, and are part of Health Canada’s Action Plan on Medical Devices launched in December 2018.

Health Canada unveiled the device safety action plan framework on the heels of an in-depth report by the International Consortium of Investigative Journalists (ICIJ) that exposed inadequate testing of medical devices and underreporting of injuries and deaths linked to the products.

Called the Implant Files, the ICIJ report found problems with approval and monitoring practices for medical devices in many countries. In Canada, the report showed that devices were suspected to have contributed to more than 14,000 reported injuries and 1,416 deaths over the past 10 years. In its wake, Canadian Minister of Health Ginette Petitpas Taylor pledged to accelerate efforts to improve the country’s device regulations.

The latest proposed rule changes would require medical device manufacturers to assess the safety of their products and do further safety testing, if requested, when issues are identified.

Manufacturers would be required to provide an analysis of the safety and effectiveness of their product so that Health Canada could conduct a post-market safety review. Companies also would be required to prepare annual summary reports of all known adverse effects, reported problems, incidents and risks, and notify Health Canada if there has been a change to the risks or benefits of a product.

Regulations introduced by Vanessa’s Law pertaining to drugs went into effect in 2018 with the intent of improving Health Canada’s ability to collect post-market safety data and take action when a serious health risk is identified. Health Canada’s current proposal would extend those rules to medical devices.