Health Canada Investigational Testing Medical Devices

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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

Health Canada will issue a “Letter of Authorization” for investigational testing of Class III and IV medical devices, if the application meets the requirements stated in Part 3 of the Regulations, although …

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Draft Guidance Document: Applications for Medical …

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This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy develops. …

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 protocol, and problem reporting. Moving forward, Health Canada intends to review this guidance document regularly to respond to stakeholder …

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

OUR MISSION: To ensure that the drugs, medical devices, and other therapeutic products available in Canada are safe, effective and of high quality. February …

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, …

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.html

Medical Device Directorate, Device Licensing Services Division Health Canada 11 Holland Avenue Address Locator 3002A Ottawa, Ontario K1A 0K9 By email: meddevices …

Class II – IV Medical Device Investigational Testing in …

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

Devices must be labeled “for investigational use only”, and a Class I medical device does not require investigational testing authorization. The Health Canada application should include: A protocol which details the …

Health Canada Update on Investigational Testing …

https://capra.ca/en/blog/health-canada-update-on-investigational-testing-authorizations-for-medical-devices-2018-10-29.htm

Health Canada Update on Investigational Testing Authorizations for Medical Devices Published on October 29, 2018 Author: Pinky Mazumder …

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

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

Medical Devices Regulations 1 - Interpretation 2 - Application 6 - Classification of Medical Devices 8 - PART 1 - General 8 - Application 9 - Manufacturer’s Obligations 10 - Safety …

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