Canadian Health Information Management Association Practice Exam

Which organization reviews medical devices for safety, effectiveness and quality before they are authorized for sale in Canada?

1. CHI.

2. CIHI.

3. Health Canada.

4. Public Health Agency of Canada.

The correct answer is: Health Canada.

Health Canada is the organization responsible for reviewing medical devices to ensure their safety, effectiveness, and quality before they can be authorized for sale in Canada. This responsibility is crucial because medical devices can significantly impact patient health and safety. Health Canada evaluates the scientific evidence related to the medical device, which includes assessing clinical data and manufacturing practices, to determine whether the device meets the regulatory requirements established under Canadian law. The other organizations mentioned have different mandates. For instance, the Canadian Health Information (CHI) focuses on promoting the use of health information for improved healthcare delivery and does not engage in product regulation. The Canadian Institute for Health Information (CIHI) is dedicated to collecting and analyzing health data but does not review medical devices. Similarly, the Public Health Agency of Canada works on public health issues, such as disease prevention and health promotion, which does not include regulatory oversight of medical devices. Understanding these distinctions highlights the specific role Health Canada plays in ensuring the safety and quality of medical devices available to Canadians.