Medical Device Health Canada

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Medical devices - Canada.ca

(Just Now) 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.html

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Medical Devices Active Licence Listing (MDALL) - Your …

(8 days ago) WEBMedical Devices Active Licence Listing (MDALL) - Your reference tool for licensed medical devices in Canada. From Health Canada. Dear visitor, We have reorganized our Web …

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

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Health product highlights 2021: Medical devices

(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 for the treatment, …

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

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Guidance on summary reports and issue-related …

(2 days ago) WEBWith respect to issue-related analyses, Health Canada may request an analysis from a manufacturer of a Class I medical device or a licence holder of a Class II to IV medical …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-eng.pdf

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Guidance on clinical evidence requirements for …

(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 Regulations ( SOR /98-282) - Site Web de la

(9 days ago) WEB43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

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Health Canada: Post-market surveillance on medical device - BLG

(7 days ago) WEBOn December 23, 2020, Health Canada published SOR/2020-262 – Regulations Amending the Food and Drug Regulations and the Medical Device …

https://www.blg.com/en/insights/2021/11/health-canada-regulatory-spotlight-on-medical-device-post-market-surveillance

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Guidance Document

(2 days ago) WEBMedical Devices Directorate, Health Canada 11 Holland Avenue, Address Locator: 3002A OTTAWA, Ontario K1A 0K9 Email: hc.devicelicensing …

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

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GUIDANCE DOCUMENT

(2 days ago) WEBHow to Complete the Application for a Health Canada New Medical Device Licence Guidance Document 4 Revised Date: 2017/12/29; Effective Date: 2018/03/16 Item 3: …

https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-22-2019-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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Regulations and standards - ic

(Just Now) WEBRegulations and standards. In Canada, approvals for medical devices are obtained through Health Canada's Therapeutic Products Directorate, which applies the Food and Drug …

https://ised-isde.canada.ca/site/canadian-life-science-industries/en/medical-devices/regulations-and-standards

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Medical Devices Drug and Health Products Portal

(2 days ago) WEBThis system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an …

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

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBMedical devices include a range of health products, including: bandages/adhesive strips (Class I) crutches and canes (Class I) medical devices in Canada, including medical …

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

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Health Canada Responds To Medical Device Regulation Gaps

(4 days ago) WEBIn late 2018, a series of news articles took aim at Canada's regulation of medical devices, alleging that Health Canada's medical device approval and adverse …

https://www.mondaq.com/canada/healthcare/804696/health-canada-responds-to-medical-device-regulation-gaps

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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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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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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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Medtronic receives Health Canada licence for MiniMed 780G system

(1 days ago) WEBMedtronic Canada announced that Health Canada has granted a license to its MiniMed 780G insulin pump system for use by people living with type 1 diabetes. The …

https://www.nsmedicaldevices.com/company-news/medtronic-receives-health-canada-licence-for-minimed-780g-system/

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Medical device regulations, classification & submissions Canada, …

(1 days ago) WEBCanada i: Medical Devices Regulations (SOR/98–282). Schedule 1. For class II, III or IV medical devices, the company must obtain a medical device license issued by Health …

https://learn.marsdd.com/article/medical-device-regulations-classification-and-submissions/

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KA Imaging’s mobile X-ray licenced by Health Canada

(8 days ago) WEBWATERLOO, Ont. – A Canadian Medical Device Licence was issued by Health Canada for Reveal Mobi Pro, KA Imaging’s premium dual-energy mobile system. …

https://www.canhealth.com/2024/05/15/ka-imagings-mobile-x-ray-licenced-by-health-canada/

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Government of Canada supports development & point-of-care …

(6 days ago) WEBAMR is a serious threat to human and animal health. Essential medical interventions such as organ transplantations, joint replacements and chemotherapy are …

https://www.canada.ca/en/public-health/news/2024/05/government-of-canada-supports-development--point-of-care-dissemination-of-national-antimicrobial-prescribing-guidelines.html

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Medical Device Market and Future Trends Discover DHL

(5 days ago) WEBPACKAGING For devices containing batteries, there will be some guidelines to follow to assure their safe transit. This guide to shipping batteries will ensure your …

https://www.dhl.com/discover/en-at/industry-insights/life-science-healthcare/medical-devices-sector-guide

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Innovate UK funds digital health compliance platform - Medical …

(6 days ago) WEBAI will be a key driver of healthcare innovation, according to GlobalData medical device analyst Joselia Carlos. According to a report on GlobalData’s Medical …

https://www.medicaldevice-network.com/news/innovate-uk-funds-digital-health-compliance-platform/

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FDA clarifies definition of 'remanufacturing' for medical devices

(1 days ago) WEBThe Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or …

https://www.aha.org/news/headline/2024-05-09-fda-clarifies-definition-remanufacturing-medical-devices-needing-maintenance

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Attendant, Medical Device Reprocessing-Jim Pattison Outpatient …

(Just Now) WEBFraser Health Authority is hiring a Attendant, Medical Device Reprocessing-Jim Pattison Outpatient Care & Surgery Centre in Surrey, Canada. Review all of the job details and …

https://jobs.fraserhealth.ca/jobs/68437?lang=en-us

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