Document background
The Medical Device Supply Agreement is essential for organizations involved in the supply chain of medical devices in Canada. This agreement is typically used when establishing a formal relationship between medical device manufacturers or suppliers and healthcare institutions, distributors, or facilities that purchase medical devices. The document ensures compliance with Canadian regulatory requirements, including the Food and Drugs Act and Medical Devices Regulations, while addressing commercial aspects such as supply terms, quality standards, and risk allocation. It includes crucial provisions for regulatory compliance, quality management, adverse event reporting, and post-market surveillance, making it suitable for both single-device arrangements and comprehensive supply relationships. The agreement is particularly important given Canada's strict regulatory framework for medical devices and the need to ensure patient safety and healthcare standards.
