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Protected A (When completed)Medical Device Recall Reporting Form Initial Purpose: To capture the information manufacturers and importers are required to report to Health Canada on or before undertaking
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What is medical device recall reporting?
Medical device recall reporting is a process where manufacturers or distributors notify the appropriate regulatory agency about a device that is defective or poses a risk to the health and safety of patients.
Who is required to file medical device recall reporting?
Manufacturers, distributors, and importers of medical devices are required to file medical device recall reporting.
How to fill out medical device recall reporting?
Medical device recall reporting can be filled out online through the regulatory agency's website or submitted through mail or email.
What is the purpose of medical device recall reporting?
The purpose of medical device recall reporting is to protect the health and safety of patients by identifying and removing unsafe medical devices from the market.
What information must be reported on medical device recall reporting?
The information reported on medical device recall reporting includes the reason for the recall, the affected product details, the potential risks to patients, and the proposed corrective actions.
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