Health Canada Medical Device Clinical Trials

Notice: Clinical trials for medical devices and drugs

https://www.canada.ca/en/health-canada/services/clinical-trials/notice-medical-devices-drugs-covid-19-regulations.html

Applications for Medical Device Investigational Testing

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

2.1 Abbreviations and definitions. 2.1.1 Abbreviations. CTA. Clinical Trial …

Guide on applications for COVID-19 medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/covid-19-clinical-trials.html

conduct a clinical trial for a COVID-19 medical device, as authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations …

Clinical trials and drug safety - Canada.ca

https://www.canada.ca/en/health-canada/services/clinical-trials.html

A clinical trial involves travel, tests and possible hospital stays, which can take up a lot of your time. Reduce your risk. If you participate in a clinical trial, you should understand …

Medical devices - Canada.ca

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

Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, …

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

Clinical trials in healthy volunteers. Health Canada authorizes clinical trials involving healthy volunteers, such as bioavailability or bioequivalence trials, first-in-human trials (that is, …

Applications for Medical Device Investigational Testing

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

2.3.3.2 Devices used in drug clinical trials (pharmaceuticals and biologics) 2.3.3.3 Combination products and joint reviews. 2.3.4 Organization of an ITA Application. 2.3.5 …

Draft Guidance Document: Applications …

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

To provide assistance to manufacturers and importers in preparing the documentation necessary to obtain an authorization for the sale or importation of a medical device under an Investigational …

Health Canada Issues Final Guidance on Clinical …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

This guidance outlines the general principles and criteria for clinical evidence that may be required for Class III and IV license applications or requested for certain Class II license applications …

Medical Device Clinical Trials: Regulatory …

https://www.greenlight.guru/blog/medical-device-clinical-trials

Clinical trials are generally performed within an institution, such as a hospital, and an IRB is an additional layer of scrutiny that the institution provides to ensure the study meets its …