Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps

Name: Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada
Keywords: applications,changes,class-2,class-3,class-ii,class-iii,evidence,guidances,infusion-pumps,medical-devices,notices,requirements,support,testing

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Guidance Documents

Published

August 13, 2018

Last updated

March 18, 2021

Description

Delivery accuracy testing requirements for infusion pumps to support new and amended medical device licence applications.

Organization

Health Canada 🇨🇦

Country / Region

Canada

License

Open Government License 2.0 (Canada)

Feedback

Suggest an improvement to this page

4 Main files

Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps

Updated on March 18, 2021

html

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-evidence-infusion-pumps.html
Permalink: https://data.openrid.co/en/datasets/r/d22ed591-26a3-4965-84a4-e839246bd64a
MIME Type: text/html

Created on: August 13, 2018
Modified on: March 18, 2021

Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps

Updated on March 18, 2021

pdf

URL: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209337.pdf
Permalink: https://data.openrid.co/en/datasets/r/5d87c761-887e-4b2a-925c-91c3df0038e5
MIME Type: application/pdf

Created on: August 13, 2018
Modified on: March 18, 2021

Avis : Changements apportés aux exigences en matière de données probantes portant sur les pompes à perfusion de classe II et III

Updated on March 18, 2021

html

URL: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/activites/annonces/avis-exigences-pompes-perfusion.html
Permalink: https://data.openrid.co/en/datasets/r/0b8c2cd5-f3ac-4ec4-827f-a60d46766a33
MIME Type: text/html

Created on: August 13, 2018
Modified on: March 18, 2021

Avis : Changements apportés aux exigences en matière de données probantes portant sur les pompes à perfusion de classe II et III

Updated on March 18, 2021

pdf

URL: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209337.pdf
Permalink: https://data.openrid.co/en/datasets/r/75eca35a-a6c4-4297-be9c-a1af8641b81f
MIME Type: application/pdf

Created on: August 13, 2018
Modified on: March 18, 2021

Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

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