Submission Templates are developed by MEDEC’s Pre-Submission sub-committee with input from the staff at the Medical Devices Bureau in an effort to standardize the interpretation and requirements for device submission. The templates are created by taking the requirements from existing guidance documents, input/feedback from Medical Devices Bureau, Industry best practices and consolidating these requirements into a presentable format. These templates are “tools” for manufacturers to use and are not mandatory for device submission to Health Canada.

Please feel free to use the templates as a starting point but be mindful, some modifications may be required to fit your specific product.

• Executive Summary Template for Medical Devices
  
• Executive Summary Template for IVDD
• Marketing History Template
  

If you have any comments/suggestions for improvement, please reach out to Debbie Gates. We will use your feedback to continually update and improve the template.