Get Canada Medical Device Problem Report Form For Health Care Professionals 2019-2024

ing to Canada's Food and Drugs Act, medical device manufacturers or importers must submit incident reports to Health Canada. This is referred to as Mandatory Problem Reporting (MPR).

ISO 13485 is a quality system standard designed specifically for medical device companies. It is the most common path to meet the Quality Management System (QMS) medical device requirements in Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries like Japan, Korea, and Brazil.

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement.

Therefore, the CE mark is relevant in Europe and other parts of the world, but not in Canada nor the United States.

Canada QMS requirements for medical device companies Manufacturers of medical devices classified as Class II, III, and IV must demonstrate compliance with ISO 13485 under MDSAP.

Medical devices are classified ing to Health Canada's risk-based system. There are four device classifications — Class I, II, III and IV — using a set of 16 rules found in Canadian Medical Devices Regulations. In vitro diagnostic (IVD) devices are also classified as Class I through IV using a set of nine rules.

A summary report is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. The summary report regulatory requirement does not apply to Class I devices.

Contact. For additional information on the Canada Vigilance Program or about mandatory reporting of serious ADRs/MDIs: Call toll free 1-866-234-2345. Email hc.canada.vigilance.sc@canada.ca.