Health Canada Mandatory Reporting Procedures

 Health Canada encourages manufacturers, importers and device user facilities to report any medical device related issues that have occurred during device examination, testing or use. All the issues related to safety, effectiveness or quality of medical device must be reported to Health Canada. This helps the manufacturers to carry out an effective and timely investigation of the incident and for timely recall of the device.

ADB Consulting follows a set of procedures that help manufacturers submit an efficient and quick reporting of issues to Health Canada within the deadlines. Our professionals have years of experience responding to and documenting adverse events caused due the use of a particular medical device and ensure that it efficiently meets the compliance while protecting the company from litigations.

Our mandatory reporting procedures document the adverse incidents pertaining to a defect or characteristic of medical device or incorrect or insufficient instruction on the packaging or label or incomplete information on terms of use and more.

 

 


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