Canada – Health Canada Consults on New Proposed Device Regulations

Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices.

Specifically, the agency is proposing regulations that would amend the 2014 Protecting Canadians From Unsafe Drugs Act, commonly known as Vanessa’s Law, to extend some of its provisions to medical devices.

Under the proposal, device makers would be required to provide annual summary reports of adverse events and to notify Health Canada if there have been any changes to a device’s benefits and risks.

The proposed regulations would also give the government authority to request safety assessments or order new safety testing for marketed devices, as well as to require device makers to provide analyses of the safety and effectiveness of their products to enable Health Canada to conduct postmarket safety reviews…