Health Canada Medical Device Reporting Form

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Report a medical device problem (for health care professionals)

(6 days ago) WEBReporting by hospitals is required Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to …

https://hpr-rps.hres.ca/side-effects-reporting-form.php?form=medical_devices

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Mandatory Medical Device Problem Reporting Form for Industry

(2 days ago) WEBInstructions on Completing the Mandatory Medical Device Problem Reporting Form. Publisher - Current Organization Name: Health Canada. Licence: Open Government …

https://open.canada.ca/data/en/info/3cac3c79-a850-47c9-b0b6-26efad748865

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Incident reporting for medical devices : guidance document.

(5 days ago) WEBOttawa, ON : Health Canada = Santé Canada, 2021. ©2021 : Description : 1 online resource (iii, 15 pages) ISBN : 9780660370422 : Catalogue number : H164-310/2021E …

https://www.publications.gc.ca/site/eng/9.895027/publication.html

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Guidance on summary reports and issue-related analyses for …

(2 days ago) WEBmedical devices used in Canada. We can then decide on the necessary action to help protect the health and safety of Canadians. Scope and application Medical device …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-eng.pdf

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Guidance document for mandatory problem reporting for medical …

(3 days ago) WEBCanada. Health Canada. Title : Guidance document for mandatory problem reporting for medical devices : Canada Vigilance - Medical Device Problem Reporting Program : …

https://www.publications.gc.ca/site/eng/432106/publication.html

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Health Canada Adverse Event Reporting for Medical Devices

(9 days ago) WEBHere are the basic steps you should follow in reporting an adverse event in Canada: Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance …

https://www.emergobyul.com/services/health-canada-adverse-event-reporting-medical-devices

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Medical Device Incidents - Drug and Health Product Register

(9 days ago) WEBReport a medical device problem (for health care professionals) Prescription Drug List; About . Questions and Answers - Prescription Drug List; Feedback; Search Medical …

https://hpr-rps.hres.ca/mdi_landing.php

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Medical Devices Drug and Health Products Portal

(2 days ago) WEBThe incidents in this database represent the perspective of those who send Health Canada the reports. Report a medical Device Problem (For Health Care Professionals) The …

https://dhpp.hpfb-dgpsa.ca/medical-devices

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Quality Assurance Management Quality Module (QM-0007)

(6 days ago) WEBQM-0007 – QAM Quality ModuleHealth Canada. Protected Awhen completed. 2. Authorization for medical devices mandatory problem, foreign risk notification, and …

https://wiki.gccollab.ca/images/5/53/FRM-0090_Authorization_for_medical_devices_mandatory_problem_foreign_risk_notification_and_recall_reporting_EN_v22.docx

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Health Canada on Incident Reporting: Timelines and Content

(1 days ago) WEBHealth Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the …

https://www.regdesk.co/health-canada-on-incident-reporting-timelines-and-content/

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Medical Device Foreign Risk Notification Form for Industry

(3 days ago) WEBCompleted forms should be submitted by email to Health anada’s Medical Devices Directorate at: [email protected] * The …

https://wiki.gccollab.ca/images/4/46/HC_Medical_Device_FRN_Form_V1_EN.pdf

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File:FRM-0090 Authorization for medical devices mandatory

(9 days ago) WEBDate/Time Dimensions User Comment; current: 12:09, 9 June 2021 (111 KB) Hc.mdd.postmarket-postcommercialisation.dim.sc (talk contribs): Authorization for …

https://wiki.gccollab.ca/File:FRM-0090_Authorization_for_medical_devices_mandatory_problem_foreign_risk_notification_and_recall_reporting_EN_v22.docx

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Guidance document : how to complete the application for a new …

(1 days ago) WEBIssued by: Health Products and Food Branch. Issued also in HTML format. Includes bibliographical references. Publishing information [Ottawa] : Health Canada = Santé …

https://publications.gc.ca/site/eng/9.859846/publication.html

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Medical Devices Regulations Summary Reports - GCcollab

(6 days ago) WEBSummary Reports –Preparation and maintenance 7 61.4 (1) The holder of a medical device licence shall prepare a summary report Who is responsible for preparing, …

https://wiki.gccollab.ca/images/9/9c/MedTech_2021_Summary_Reports_GCwiki.pdf

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