Health Canada Guidance For Medical Device Complaint Handling And Recalls

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Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

The manufacturer and importer of a medical device shall, as soon as possible after the completion of a recall, each report to Health Canada: the results of the recall. the action taken to prevent a recurrence of the problem. Manufacturers and importers must …

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

2.9.1 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 …

Guidance documents – Medical devices - Canada.ca

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

Fees for Medical Devices. For fee-related guidance documents and forms, please visit Fees for Medical Devices. Notice: Guidance Document Updates to Reflect …

Recalls - Canada.ca

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

Defines 'recall' for health products and medical devices with links to related recall lists and procedures. ... Adverse reactions, medical device incidents and health …

Guidance on Investigation of Reported Medical Device

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/guidance-investigation-reported-medical-device-problems-0065.html

Manufacturers should incorporate sound risk management principles in their problem investigation procedures. One approach that provides internationally recognized …

Recall policy for health products - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/recall-policy-0016/policy.html

Table 2: Medical Devices Person Applicable Legislation Requirements; Sellers (incl. persons distributing not for consideration) Section 21.3(1) and 31.2 of the Food …

Reporting complaints about health products - Canada.ca

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

Examples of other types of complaints and where to report; Health products. Health products are regulated under the Food and Drugs Act and its Regulations. Health …

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) …

Health Canada Guidance on Recalls: …

https://www.regdesk.co/health-canada-guidance-on-recalls-basics/

Jul 22, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical …

Medical Device Complaint Form (FRM-0317) - Canada

https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html

Medical Device Complaint. If you are a consumer looking to report a problem with a medical device, access this online form. If you are an industry representative, looking to …

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