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Medical Device Regulatory Requirements for Canada Updated: June 2011 Disclaimer: The information contained in this profile is derived from public sources, is intended to assist U.S. exporters in performing
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What is medical device profile 6-11?
Medical device profile 6-11 is a form used to provide information about a specific medical device.
Who is required to file medical device profile 6-11?
Manufacturers or distributors of medical devices are required to file medical device profile 6-11.
How to fill out medical device profile 6-11?
Medical device profile 6-11 can be filled out online or submitted in paper form by providing information about the medical device such as the manufacturer, intended use, risk classification, and labeling.
What is the purpose of medical device profile 6-11?
The purpose of medical device profile 6-11 is to ensure that regulators have accurate and up-to-date information about medical devices in order to monitor their safety and effectiveness.
What information must be reported on medical device profile 6-11?
Information such as the manufacturer's name and address, device description, intended use, risk classification, and labeling must be reported on medical device profile 6-11.
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