Clinical Trial Medical Device Canada

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, 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 …

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 …

Medical devices - Canada.ca

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

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, mitigation, diagnosis …

Guidance 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

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

The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (Regulations) were published on March 2, 2022. They came into effect on February 27, …

Draft Guidance Document: Applications for …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

This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be …

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 …

Clinical Trial Applications (CTAs) - Canada.ca

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

Clinical Trial Application ( CTA) The CTA is composed of three parts (modules): Module 1 - contains administrative and clinical information about the proposed trial. Module 2 - …

Medical Device Clinical Trials: Regulatory …

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 …

Class II – IV Medical Device Investigational …

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

In Canada, Sponsors or Manufacturers should submit an Investigational Testing Application “ITA” to use unapproved Class II, III, and IV devices in clinical trials to the Device …