Health Canada Medical Device Mandatory Reporting

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Mandatory Medical Device Problem Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-medical-device-problem-reporting-form-industry-adverse-reaction-reporting.html

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Incident reporting for medical devices: Guidance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

Submission of inadequate incident reports by reporters, for which Canada Vigilance - Medical Device Problem Reporting Program is consistently required to …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Updates to list of medical devices for mandatory shortage reporting: Notice [2022-02-10] Webinar tutorial on the 2022 annual licence review application process …

Problem Reporting - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting.html

Mandatory Problem Reporting for Medical Devices. Preliminary Report Form (FRM-0237) Final Report Form (FRM-0238) Preliminary and Final Report Form (FRM-0255) …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Medical Devices Guidance Documents. Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10] The Health Canada eSTAR pilot program [2023-01 …

ARCHIVED: Guidance Document for Mandatory Problem …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-mandatory-problem-reporting-medical-devices-health-canada-2011.html

A mandatory problem report is required under the Regulations for any incident involving a medical device that is sold in Canada when the incident: relates to a …

Mandatory reporting requirements for hospitals - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting.html

Medical Devices Regulations for medical device incidents; Which hospitals must report. The mandatory reporting regulatory requirements apply to hospitals that are: licensed, …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …

Mandatory Adverse Reaction Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-adverse-reaction-reporting-form-industry.html

Mandatory Adverse Reaction Reporting Form for Industry. Reports must be made within 15 calendar days of receiving or becoming aware of the information about the adverse …

Health Canada Medical Device Adverse Event Reporting - Emergo

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

Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance Document for Mandatory Problem Reporting for Medical Devices for the correct reporting …

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