Drugs and Medical devices (ICS: 11.040, 11.120)

Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) (43 pages, available in English and French)

The proposed regulations will modify the Medical Device Regulations (MDR) and the Food and Drug Regulations (FDR) in order to operationalize provisions in the 2014 Protecting Canadians from Unsafe Drugs Act, as well as to add certain post-market surveillance provisions for medical devices. The provisions that are being proposed to be added to the MDR include:

a) allowing the Minister of Health (the Minister) the power to compel an assessment of a marketed medical device;

b) allowing the Minister the power to compel additional tests and studies regarding a marketed medical device;

c) requiring product authorization holders to provide information about foreign risk actions for their products;

d) requiring medical device manufacturers to prepare annual summary reports; and

e) providing the Minister with the power to request that medical device manufacturers provide an analysis of the safety and effectiveness of their products for the purpose of conducting a post-market safety assessment. Minor amendments will be made to the FDR to support the changes to the Medical Device Regulations.