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Submission Tools for Licence Applications
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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.

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.

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MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our publicly-funded health care system. We are committed to supporting the growth of a strong and vibrant medical technology industry that contributes to Canada’s innovation economy.



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