Medical Device Clinical Trials Canada

Health Canada's Clinical Trials Database

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

Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients ... Clinical trials conducted with natural health products and medical devices. Health Canada also authorizes trials involving natural health products and devices; however ...

Clinical Trials for Medical Devices | dicentra.com

https://dicentra.com/clinical-trials-for-medical-devices

dicentra is a full-service clinical research organization for medical devices located in Toronto, Canada. Whichever market you’re targeting - we design and conduct clinical …

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 …

Clinical trials and drug safety - Canada.ca

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

Draft Guidance Document: Applications for Medical …

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

Information on investigational testing of medical devices in Canada can be obtained directly from the manufacturer, or by consulting one of the registries. ... 2.3.3.2 Devices used in Drug Clinical Trials. …

Clinical Research Regulation For Canada | ClinRegs

https://clinregs.niaid.nih.gov/country/canada

Health Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for 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

Scope and application. This guidance outlines the requirements when applying for a clinical trial authorization involving a COVID-19 medical device (defined …

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

2.3.2.3 WIP pulse sequences for magnetic resonance imaging devices; 2.3.3 Filing an ITA application. 2.3.3.1 Multiple devices used in one study; 2.3.3.2 Devices used in drug …

Medical Device Clinical Trials: Regulatory Pathways

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

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained. Written by: Jon Bergsteinsson. January 1, 2023. In both the US and the EU, medical devices may be required to undergo a …

Class II – IV Medical Device Investigational Testing in …

https://vantagebiotrials.com/class-ii-iv-medical-device-investigational-testing-in-canada/

The new ISO14155-2011 “Clinical investigation of medical devices for human subjects-Good clinical practice” is more harmonized with ICH GCP but adapted for medical device trials and has been well received as a …