Health Canada Medical Device Investigational Testing

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Applications for Medical Device …

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

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

Draft Guidance Document: Applications for …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This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be …

Investigational Testing Authorizations Guidance

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/investigational-testing-authorizations-guidance.pdf

investigational testing, and REB information is required for all clinical trials involving medical devices by Part 3, section 81 of the Regulations. Health Canada will issue a …

Preparation of an Application for Investigational Testing

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cover-letter-application-investigational-vitro-diagnostics-devices.html

For more information on how to prepare an application for investigational testing for IVDD medical devices please contact: Device Evaluation Division Medical …

How Health Canada inspects medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html

Also known as a clinical trial or study, investigational testing is a research study of 1 or more human subjects to assess the safety or performance of a medical …

Management of applications for medical device licences …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations/guidance-document.html

Class III and Class IV device licence applications will be identified as deficient if the review components are not provided in sufficient detail as described in the …

Class II – IV Medical Device Investigational …

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

Investigational Testing in Human Clinical Trials In Canada, Sponsors or Manufacturers should submit an Investigational Testing Application “ITA” to use unapproved Class II, III, …

Management of Applications for Medical Device Licences

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Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

69 - PART 2 - Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access 69 - Application 70 - General 71 - Authorization 73 - Additional …

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