Health Canada Outlines 2007-2012 Strategic Plan for Medical Devices

Health Canada has announced a five-year plan for the Medical Devices Program (MDP) that includes new measures to increase risk management of clinical trials and postmarket activities, punish firms that fail to comply with MDP regulations, and stem the distribution and sale of counterfeit devices.

The MDP currently oversees approximately 1,600 licensed medical device establishments and more than 60,000 licensed medical devices, the agency said. With the number of products “continuing to grow exponentially, it is increasingly challenging to maintain the level of service Canadians and industry require within the current budget,” the plan says.

The plan also addresses human resource and finance issues. According to Health Canada, the MDP had approximately 150 full-time employees and a budget of more than $11 million in fiscal 2005-2006.