Health Canada Complaint Handling Guidance

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Reporting complaints about health products - Canada.ca

(Just Now) People also askHow does Health Canada handle health product complaints?Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and Enforcement Branch (ROEB). ROEB manages health product complaints on a priority basis according to the risk to people's health and safety, with those considered high-risk receiving first priority.Reporting complaints about health products - Canada.cacanada.caWhat is Health Canada's compliance guidance?It describes what a company's procedures should contain and what kinds of records should be kept in order to comply with the Regulations. The guidance is also intended to promote transparency and consistency respecting Health Canada's role in assessing compliance with these requirements.Guidance on Investigation of Reported Medical Device Problems (GUI-0…canada.caHow do I report a medical device to Health Canada?Discuss treatment options and the potential benefits and risks of medical devices with your healthcare provider. Contact your healthcare provider if you have any health concerns related to your use of a medical device. Report complaints involving medical devices to Health Canada by calling toll-free at 1-800-267-9675, or by reporting online.Health Canada encourages Canadians to report incidents involving recalls-rappels.canada.caDo I need to notify Health Canada of foreign risk actions?2. Notifying Health Canada of foreign risk actions Regulations are necessary for this provision, as the existing mandatory incident reporting requirements for foreign incidents do not provide sufficient information for licensed and higher-risk products. 3. Summary reportsRegulations Amending the Food and Drug Regulations and the Medical gazette.gc.caFeedbackCanada.cahttps://www.canada.ca/en/health-canada/services/Guidance on Investigation of Reported Medical Device2.1 Regulatory requirementsThis guidance applies to sections 57 and 58(a) of the Regulations under the heading Complaint Handling. Section 57 requires the maintenance of records and section 58(…2.2 To whom the regulatory requirements apply See moreOverviewContact Information: Letter - Guide for Investigation of Reported Medical Devices Problems (GUI-0065)Our Mandate:To promote good nutrition and informed use of drugs, food, m… See moreTable of contents•1.0 Purpose•2.0 Scope•2.1 Regulatory requirements•2.2 To whom the regulatory requirements apply•3.0 Glossary of terms See moreDisclaimerThis document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-process-summary.html#:~:text=On%20this%20page%201%20Health%20products%202%20Examples,other%20types%20of%20complaints%20and%20where%20to%20report

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Incident reporting for medical devices: Guidance document

(1 days ago) Web2.9.1 Preliminary report for an incident occurring in Canada. Section 60 (1) ( a) of the Regulations requires that if the death or serious deterioration in health of the patient, user or other person has occurred, …

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

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Canada Gazette, Part 2, Volume 154, Number 26: …

(2 days ago) WebSince the globally accepted ISO standards require complaint handling and risk management processes to include regular trending and signalling tools to identify …

https://gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html

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Guidance on summary reports and issue-related …

(2 days ago) Webthe preparation, retention and submission of summary reports (sections 61.4 to 61.6) the completion of issue-related analyses of safety and effectiveness (sections 25(1) and 39) …

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

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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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Health Canada encourages Canadians to report incidents …

(2 days ago) WebReport complaints involving medical devices to Health Canada by calling toll-free at 1-800-267-9675, or by reporting online. Stay connected with Health Canada and receive the …

https://recalls-rappels.canada.ca/en/alert-recall/health-canada-encourages-canadians-report-incidents-involving-medical-devices-help

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Medical Devices Regulations ( SOR /98-282) - Site Web …

(9 days ago) Web57 - Complaint Handling; 59 - Incident Reporting; 61.2 - Serious Risk of Injury to Human Health; 61.4 - Summary Report; 62 - Provision of Information Under Section 21.8 of Act; …

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

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Canada Gazette, Part 1, Volume 157, Number 15: …

(1 days ago) WebHealth Canada relies on policy and guidance to request certain information to assess non-compliant products and their risks to health, and to set out timelines for …

https://canadagazette.gc.ca/rp-pr/p1/2023/2023-04-15/html/reg1-eng.html

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Drugs and Health Products - Welcome to the Health Canada Web …

(5 days ago) WebPurpose. This guide is intended to assist in the drafting of risk communications, using the standardized template to communicate health product safety …

https://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2015-temp-mod_rc-cr-guide-eng.php

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Health Canada Medical Device Adverse Event Reporting - Emergo …

(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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Guidance on releasing information from adverse reaction and …

(2 days ago) WebThey also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively. Guidance documents are …

https://publications.gc.ca/collections/collection_2022/sc-hc/H164-343-2022-eng.pdf

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Medical Device Incidents - Drug and Health Product Register

(9 days ago) WebNatural Health Products; Medical Devices; Review Decisions . Summary Safety Review; Summary Basis of Decision; Regulatory Decision Summary; Submit a report . Report a …

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

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Report a health and safety concern - Canada.ca

(4 days ago) WebIt’s important to report side effects, injuries and other product-related health and safety concerns so we can make important safety decisions about the products you use. If …

https://www.canada.ca/en/services/health/report-health-safety-concern.html

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Health Canada Guidance on Problem Report Investigation

(1 days ago) WebSep 15, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of reported …

https://www.regdesk.co/health-canada-guidance-on-problem-report-investigation-collecting-information/

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(Just Now) WebApplication for an Authorization. 68.1 (1) The Minister may add a medical condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-7.html

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Incident reporting for medical devices: Guidance document

(2 days ago) WebIncident reporting for medical devices: Guidance document. Effective Date: June 23, 2021 Supersedes: October 3, 2011 Health Canada is responsible for helping Canadians …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-310-2021-eng.pdf

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Complaint-handling process search tool - Canada.ca

(3 days ago) WebSearch by using only part of the name of the entity. For example, “Scotia” or “Montreal.”. If you’re having difficulty finding the complaint-handling process you’re …

https://itools-ioutils.fcac-acfc.gc.ca/CHP-PTP/Complain-outilder-eng.aspx

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Guidance Document

(2 days ago) WebHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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Guideline on Complaint-Handling Procedures for Banks and …

(1 days ago) WebA Bank’s complaint-handling Policies and Procedures should include: 18.1. initial and ongoing formal training on complaint-handling for all Employees who deal …

https://www.canada.ca/en/financial-consumer-agency/services/industry/commissioner-guidance/complaint-handling-procedures-banks.html

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