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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
- Use the Medical Device Recall Reporting Form - Initial (FRM-0360) to complete your initial recall report. Submit a section 65 final report to your nearest Health Canada regional office as soon as possible after completing the recall. Use the Medical …
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
- A correction can also be a recall to address nonconforming devices in distribution. Note: A nonconformity may include a problem or malfunction with the device Corrective Action …
Recalls - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls.html
- ARCHIVED - Product Recall Procedures; Summary of Drug and natural health products recall guide; Compliance and Enforcement RSS Feeds; What’s new: …
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
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 device recalls. The …
PRODUCT RECALL PROCEDURES TABLE OF …
- https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/recall_proc-marche_retrait-eng.pdf
- The Health Protection Branch will provide scientific, technical and operationaladvice to the recalling firm in the development of the recall strategy as well as evaluate …
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
- Corrective actions taken as a result of the investigation: Includes information on actions taken to correct the problem, including any postmarket surveillance, recalls, or corrective …
Drug and natural health products recall …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls/guidance-drug-natural-health-products/document.html
- If consignees do not respond to the initial notification, you must follow up. “Non-responders” are people from whom you do not receive a return fax, e-mail, courier or phone message. Health …
Health Canada Guidance on Recalls: Notification and …
- https://www.regdesk.co/health-canada-guidance-on-recalls-notification-and-corrections/
- During the first two stages of a recall process, the party responsible for a medical device (e.g., medical device manufacturer) identifies the need in recall and …
ARCHIVED - Product Recall Procedures - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls/product-recall-procedures.html
- The recalling firm is given every opportunity to contribute to the information on which the health hazard evaluation is made by the Health Protection Branch who, on the basis of …
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