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Post Market Surveillance & Adverse Event Reporting What is an

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<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> <strong>an</strong>d <strong>Adverse</strong> <strong>Event</strong> reportingCitation:“The <strong>Market</strong>ed Pharmaceuticals <strong>an</strong>d Medical Devices Bureau within MHPD*conducts the following activities related to devices:• monitoring devices incident data;• reviewing <strong>an</strong>d <strong>an</strong>alysing product safety data;• detecting <strong>an</strong>d evaluating signals;• conducting benefit <strong>an</strong>d r<strong>is</strong>k assessments <strong>an</strong>d making recommendations onr<strong>is</strong>k m<strong>an</strong>agement options;• communicating product related r<strong>is</strong>ks to health care professionals <strong>an</strong>d thepublic; <strong>an</strong>d• providing policies to effectively regulate marketed health products.”End of citation.*MHPD: <strong>Market</strong>ed Health Products DirectorateSource: Health Products <strong>an</strong>d Food Br<strong>an</strong>ch of Health C<strong>an</strong>ada - Medical Devices Program - StrategicPl<strong>an</strong> 2007-2012

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