Health Canada No Objection Letter Medical Device

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Guidance Document For Clinical Trial Sponsors: Clinical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html

CTA/CTA-A: Letters authorizing Health Canada to access related files (i.e.: a previously authorized CTA, Drug Master Files, Manufacturing Site Reference Files), if …

Importing and exporting health products for commercial …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/commercial-use-health-products-guidance/document.html

Special Access Program (SAP) for Drugs and Medical Devices not available in Canada: The Special Access Program (SAP), via exemptions set out in …

Draft Guidance Document: Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html

The manufacturer and the importer of a medical device are required to report to Health Canada incidents that fall under the scope of section 59 of the …

Clinical trials or studies involving a drug, medical device …

https://uwaterloo.ca/research/office-research-ethics/research-human-participants/application-process/clinical-trials-or-studies-involving-drug-medical-device-or

Guidance Document: The Management of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html

The Medical Devices Directorate (MDD) is responsible for reviewing scientific information to assess the safety, effectiveness and quality of medical devices, …

Guidance Document: Part C, Division 5 of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100/document.html

Health Canada does not have jurisdiction over the professional standards regarding practice of medicine, which are enforced by the provincial colleges of physicians. Part …

Review of your Application - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/review-your-application.html

All Clinical Trial Applications ( CTA s) and Clinical Trial Application Amendments ( CTA-A s) are subject to a 30-day default review period from the date of receipt of a complete …

Background - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/background.html

If the application is deemed acceptable, a No Objection Letter ( NOL) will be issued within the 30-day review period. A CTA contains information and documentation to support the …

Health Canada Approval - University of Manitoba

https://umanitoba.ca/research/orec/ethics_medicine/health_canada.html

Following receipt of a CTA by a study sponsor and Health Canada's internal review, either a 'No objection letter' (NOL) or 'Not satisfactory notice' is issued by Health Canada. Any …

Health Canada's Clinical Trials Database - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html

Health Canada is the federal regulator responsible for authorizing the importation and sale of drugs for the purpose of clinical trials. This responsibility is fulfilled through the review …

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