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− | This page was developed to share resources related to the new post-market provisions under the Medical Devices Regulations, published in Canada Gazette, Part II on December 23, 2020. | + | === '''<big>Welcome!</big>''' === |
| + | This page was developed to share resources related to the Investigational Testing provisions under the Medical Devices Regulations. |
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− | If you have questions, please contact Health Canada's Medical Devices Directorate at mdd.postmarket-postcommercialisation.dim@hc-sc.gc.ca. | + | If you have questions, please contact Health Canada's Investigational Testing Authorization Division within the Medical Devices Directorate at [[it-ee@hc-sc.gc.ca]]. |
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| + | === '''<big>Links to Online Resources</big>''' === |
| + | For more information regarding Investigational Testing Authorizations please review the following resources: |
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| + | * [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance.html Applications for Medical Device Investigational Testing Authorizations Guidance Document] |
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| + | === '''<big>Forms</big>''' === |
| + | To access forms used by the Investigational Testing Authorization Division, click below: |
| + | * [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/forms/new-ita-form_fillablePDF_EN-Nov07.pdf Application for New Investigational Testing Authorization (ITA)] |
| + | * [[Media:Investigational_Testing_Notification_Form.docx|Investigational Testing Notification Form]] |
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| + | [[FR:Autorisation Dessai Experimental]] |