Health Canada Medical Device

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Medical Devices Active Licence Listing (M…

(8 days ago) Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is taking steps to further ensure the safety, effectiveness and quality … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

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Medical Devices Active Licence Listing (MDALL) - Canada.ca

(8 days ago) WEBDevice Identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalogue number of the device is often …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

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Medical Devices Directorate – Health Canada - Canada.ca

(7 days ago) WEBThe Medical Devices Directorate (MDD) reviews and authorizes the safety, effectiveness and quality of medical devices for human use in Canada. It also provides …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

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Medical device licensing - Canada.ca

(8 days ago) WEBMedical device licensing. Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database.

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

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Medical Devices Active Licence Listing (MDALL) - Your reference …

(8 days ago) WEBMDALL is a reference tool for licensed medical devices in Canada. You can search for active or archived licences by licence number, device name or device identifier. Find …

https://health-products.canada.ca/mdall-limh/index-eng.jsp

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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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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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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBIII and Class IV medical devices, not including in vitro diagnostic devices (IVDDs) • Draft Health Canada IMDRF table of contents for medical device applications This guidance …

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

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Medical Devices Establishment Licence (MDEL)Listing

(7 days ago) WEBA medical device establishment licence (MDEL) is issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a …

https://health-products.canada.ca/mdel-leim/index-eng.jsp

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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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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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Health Canada's MDALL Registration: Everything you should know

(4 days ago) WEBThe MDALL registration process consists of several steps that manufacturers must follow to obtain a medical device license. Here’s a step-by-step breakdown of the …

https://qualitysmartsolutions.com/blog/demystifying-health-canadas-mdall-everything-you-should-know-about-registering-medical-devices/

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Canada regulations news for medical devices and IVDs

(4 days ago) WEBThe amendments to the Medical Devices Regulations that published in the Canada Gazette, Part II (CGII) in 2020 are: The preparation, retention and submission …

https://www.medtechdive.com/spons/canada-regulations-news-for-medical-devices-and-ivds/611209/

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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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A Comprehensive Comparison: FDA vs. Health Canada Regulations

(Just Now) WEBHealth Canada vs. FDA Medical Devices. Another key component of FDA and Health Canada's duties is the regulation of medical equipment, which are classified by the FDA …

https://www.complianceonline.com/resources/fda-vs-health-canada-regulations.html

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Health Canada: new PMS requirements for Medical Devices

(1 days ago) WEBIn summary, the most important new requirements: 1. Safety and efficacy analysis to determine whether the device meets the requirements (section 25 (1) and …

https://www.thema-med.com/en/2021/01/25/health-canada-new-pms-requirements-medical-devices/

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Health Canada and FDA eSTAR Pilot FDA

(2 days ago) WEBUPDATE – January 27, 2023: Health Canada and the FDA launch eSTAR pilot Health Canada and U.S. Food and Drug Administration’s joint eSTAR pilot has reached its …

https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot

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GUIDANCE DOCUMENT

(2 days ago) WEBHealth Canada How to Complete the Application for a Guidance Document New Medical Device Licence Revised Date: 2017/12/29; Effective Date: 2018/03/16 3 2.2 The Medical …

https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-22-2019-eng.pdf

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Health Canada Guidance on Medical Device Recalls: Process …

(Just Now) WEBHealth Canada, a country’s regulating authority in healthcare products, has published a guidance document dedicated to recalls. The document provides an …

https://www.regdesk.co/health-canada-guidance-on-medical-device-recalls-process-explained/

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Obtaining a Health Canada Medical Device License (Case Study)

(Just Now) WEBThis article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device Licensing …

https://medicaldeviceacademy.com/health-canada-medical-device-license/

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Health Canada: Applications for Medical Devices under the

(Just Now) WEBHealth Canada has published a guidance dedicated to the applications for medical devices under the Interim Order for use in relation to the COVID-19. Interim …

https://www.regdesk.co/health-canada-applications-under-interim-order/

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Federal budget 2024: What lies ahead for Canada’s health-care …

(8 days ago) WEBFederal budget 2024: What lies ahead for Canada’s health-care system? By Katie Dangerfield Global News Posted April 14, 2024 4:00 am. Updated April 12, 2024 …

https://globalnews.ca/news/10419196/federal-budget-2024-health-care/

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Best Lift Chairs For Seniors In 2024 – Forbes Health

(1 days ago) WEBThe Vive Lift Chair smoothly raises and tilts forward to relieve pressure on the knees, hips and back and reclines in any position for rest and relaxation. The power …

https://www.forbes.com/health/accessibility/best-lift-chairs/

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