Health Canada Medical Device List

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Approved in 2020: Medical devices - Can…

(3 days ago) MDALL online query is an HTML application used to search the MDALL. A search can be done by Company Name, Company ID, Licence Name, Licence … See more

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/approved-2020-medical-devices.html

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April 18, 2024 updates to list of medical devices for mandatory

(Just Now) WEBManufacturers of Class I to IV devices and importers of Class I medical devices should check the list of medical devices regularly. As stated in sections 62.23 to …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/changes-reporting-medical-device-shortages-2024-04-18.html

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Health product highlights 2021: Medical devices - Canada.ca

(4 days ago) WEBIn 2021, we licensed 272 new Class III and 45 new Class IV medical devices. These new devices provide patients and health care professionals with new and innovative options …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/medical-devices.html

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Medical Devices Drug and Health Products Portal

(2 days ago) WEBReport a medical Device Problem (For Health Care Professionals) The incident reporting provisions in the Medical Device Regulations are intended to improve monitoring and …

https://dhpp.hpfb-dgpsa.ca/medical-devices

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Drug and medical device highlights 2020: Medical devices

(9 days ago) WEBThe number of medical device incident reports submitted to Health Canada by hospitals for medical devices increased by 620 percent in 2020. After the implementation of …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/medical-devices.html

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List of recognized standards for medical devices.: H164-270/2022E …

(1 days ago) WEBHealth Canada, issuing body. Title : List of recognized standards for medical devices. Publication type : Monograph : Language [English] Later edition : List of recognized …

https://publications.gc.ca/site/eng/9.916925/publication.html

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List of medical devices for an urgent public health need - Canada.ca

(4 days ago) WEBThis List of Medical Devices for an Urgent Public Health Need (UPHN list) is incorporated by reference in Part 1.1 of the Medical Devices Regulations (MDR).. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/license-authorizations/urgent-public-health-need/list.html

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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBHealth Canada: • Elements of real world data/evidence quality throughout the prescription drug product life cycle • Applications for medical device investigational testing …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-347-1-2023-eng.pdf

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Guidance on how to complete the application for a new …

(2 days ago) WEBThe device name indicated for a system, medical device family or medical device group family must appear, at least in part, on the label of each member device. Only one name …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-315-2021-eng.pdf

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) version 7 (April …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

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Guidance Document

(2 days ago) WEBTo provide a transparent outline of the processes Health Canada operates to manage medical device licence applications, in accordance with the Medical Devices …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-268-2019-eng.pdf

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Health Canada medical device regulations Gowling WLG

(Just Now) WEBHealth Canada will also work to improve access to the clinical data. The Medical Devices Regulations separate medical devices into the following 4 risk …

https://gowlingwlg.com/en/insights-resources/articles/2019/health-canada-medical-device-regulations/

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Health Canada Medical Device Listing OMC Medical

(Just Now) WEBHealth Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a …

https://omcmedical.com/health-canada-medical-device-listing/

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List of Medical Devices for Exceptional Importation and Sale

(5 days ago) WEBList of Medical Devices for Exceptional Importation and Sale. Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional …

https://open.canada.ca/data/en/dataset/786e4604-6197-45ed-93df-293f5159cea8

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Health Canada Medical Device Classification Consulting

(Just Now) WEBMedical devices are classified according to Health Canada’s risk-based system. There are four device classifications — Class I, II, III and IV — using a set of 16 rules found in …

https://www.emergobyul.com/services/health-canada-medical-device-classification-consulting

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9 Ways Canadian Medical Device Regulations Differ From the US

(3 days ago) WEBHealth Canada expects that manufacturers conform to the Good Clinical Practices (GCP) of ISO 14155:2011, an international standard for the clinical …

https://www.qualio.com/blog/canadian-medical-device-regulations

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Search Page - Drug and Health Product Register

(4 days ago) WEBReport a medical device problem (for health care professionals) Prescription Drug List; About . About the Drug and Health Product Register; Data and review decisions; …

https://hpr-rps.hres.ca/

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Health Canada Medical Device Classification Service — CanSummit

(4 days ago) WEBHealth Canada holds the medical device manufacturers, importers, and distributors as accountable to correctly classify their medical devices as per Health Canada …

https://www.cansummit.ca/medical-device-classification

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ARCHIVED 2. List of Medical Devices - canada.ca

(Just Now) WEBManufacturers and importers must report shortages and discontinuations of medical devices (or their components, accessories or parts) that will lead to a shortage. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/mandatory-reporting/archive11.html

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