The below General Guidance and Documents were created by and for the members. We would like to thank our collaborative members for the ongoing efforts in creating and supporting our efforts in the medtech space.
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Document Type |
Title |
Description |
Document Links |
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Guidance |
Contaminated Returns |
This document describes the standard requirements for the return of explanted and/or contaminated medical devices for inspection, analysis, investigation or disposal by the original device manufacturer or their distributor or agent. The standard requirements apply to preparation, packaging, labeling and shipping of medical devices and components that have been exposed to tissues, body fluids, known or suspected pathogens, or that have been in contact with materials exposed to any of the aforementioned contaminants. |
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Guidance |
Submission Tools |
Submission Templates were developed by Medtech Canada’s Pre-Submission sub-committee with input from the staff at the Medical Devices Directorate in an effort to standardize the interpretation and requirements for device submission. The templates were created by taking the requirements from existing guidance documents, input/feedback from Medical Devices Directorate, 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 submissions to Health Canada. |
Executive Summary Template for Medical Device Applications |
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Feedback to Health Canada |
Bill C-244 Medtech Canada Concerns |
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Feedback to Health Canada |
Bill S-5 Medtech Canada Concerns |
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