Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations

Name: Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada
Keywords: applications,authorization,canada,changes,draft,guidances,health-canada,investigational-testing,investigational-testing-authorizations,ita,medical-devices,meetings,policies,requests,requirements,testing

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Guidance Documents, Health And Safety

Published

November 20, 2017

Last updated

October 18, 2021

Description

This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy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. The document clarifies application requirements and processes, including pre-ITA meetings, format for an ITA application and filing requests for revisions to an ITA.

Organization

Health Canada 🇨🇦

Country / Region

Canada

License

Open Government License 2.0 (Canada)

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4 Main files

Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations

Updated on October 18, 2021

html

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html
Permalink: https://data.openrid.co/en/datasets/r/964d9ff6-fd44-4134-ab83-8452357f6f95
MIME Type: text/html

Created on: November 20, 2017
Modified on: October 18, 2021

Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations

Updated on October 18, 2021

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/forms/new-ITA-form_fillablePDF_EN-Sept26.pdf
Permalink: https://data.openrid.co/en/datasets/r/f4a5b5d2-6d16-43da-a4a9-7bdab222e25e
MIME Type: application/pdf

Created on: November 20, 2017
Modified on: October 18, 2021

Ebauche de la Ligne directrice : Demandes d’autorisation d’essai expérimental pour les instruments médicaux

Updated on October 18, 2021

html

URL: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/instruments-medicaux/consultation-ebauche-autorisation-essai-experimental-ligne-directrice.html
Permalink: https://data.openrid.co/en/datasets/r/578a152c-4f65-44bd-bd46-638b59572035
MIME Type: text/html

Created on: November 20, 2017
Modified on: October 18, 2021

Ebauche de la Ligne directrice : Demandes d’autorisation d’essai expérimental pour les instruments médicaux

Updated on October 18, 2021

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/forms/new-ITA-form_fillablePDF_FR-Sept26.pdf
Permalink: https://data.openrid.co/en/datasets/r/fb2b55f5-a222-4d03-b1a2-8305ab3410bc
MIME Type: application/pdf

Created on: November 20, 2017
Modified on: October 18, 2021

Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

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