Guidance on clinical evidence requirements for medical devices: Overview

Name: Guidance on clinical evidence requirements for medical devices: Overview
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada
Keywords: class-3,class-4,class-iii,class-iv,clinical-evidence,evidence,guidances,manufacturers,medical-devices,overview,requirements

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Guidance Documents

Published

November 3, 2021

Last updated

April 17, 2023

Description

This document provides guidance to manufacturers of Class III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices.

Organization

Health Canada 🇨🇦

Country / Region

Canada

License

Open Government License 2.0 (Canada)

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4 Main files

Guidance on clinical evidence requirements for medical devices: Overview

Updated on April 17, 2023

html

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices.html
Permalink: https://data.openrid.co/en/datasets/r/25761ccc-10cf-4857-abc0-c1c36725d6c0
MIME Type: text/html

Created on: November 3, 2021
Modified on: April 17, 2023

Guidance on clinical evidence requirements for medical devices: Overview

Updated on April 17, 2023

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/clinical-evidence-requirements-medical-devices.pdf
Permalink: https://data.openrid.co/en/datasets/r/56192fd0-efea-4313-a1e9-c58eafdf04e0
MIME Type: application/pdf

Created on: November 3, 2021
Modified on: April 17, 2023

Ligne directrice sur les exigences en matière de preuves cliniques pour les instruments médicaux : Aperçu

Updated on April 17, 2023

html

URL: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/exigences-matiere-preuves-cliniques-instruments-medicaux.html
Permalink: https://data.openrid.co/en/datasets/r/bcf0afa8-1594-4e52-aa2a-f7008c2a46ff
MIME Type: text/html

Created on: November 3, 2021
Modified on: April 17, 2023

Ligne directrice sur les exigences en matière de preuves cliniques pour les instruments médicaux : Aperçu

Updated on April 17, 2023

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/exigences-matiere-preuves-cliniques-instruments-medicaux.pdf
Permalink: https://data.openrid.co/en/datasets/r/6d84f628-7010-4fbb-b43a-baaa6ea47c99
MIME Type: application/pdf

Created on: November 3, 2021
Modified on: April 17, 2023

Guidance on clinical evidence requirements for medical devices: Overview

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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