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Submission Tools for Licence Applications

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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Medtech Canada is the national association representing the medical technology industry in Canada. Our association advocates for achieving patient access to leading edge, innovative technology solutions that provide valuable outcomes. 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 health care system. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities across the country.

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