Health Canada Medical Device Accessory

Listing Websites about Health Canada Medical Device Accessory

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

Category: Medical Show Health

Guidance documents – Medical devices - Canada.ca

(3 days ago) WEBDraft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28] Implementation of Advance Notice of Importation …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

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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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Medical Devices Active Licence Listing (MDALL) - Your …

(4 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/?lang=eng

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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 how to complete the application for a …

(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 …

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

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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 1 1.0 …

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

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Medical Device Accessory - Health Canada guidance / definition …

(5 days ago) WEBA device accessory is distinguished by its intended purpose/associated claim (s) to enable or support the intended use of the primary device. For example, a …

https://elsmar.com/elsmarqualityforum/threads/medical-device-accessory-health-canada-guidance-definition-on-what-an-accessory-is.76144/

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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBThe evidence required to support a medical device licence application is proportional to the risk of the device. This is determined by applying the classification rules for medical …

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

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COVID-19 guidance for reporting medical device shortages

(1 days ago) WEBUnder section 15(1) of Interim Order No. 2, manufacturers and importers must report medical device shortages to Health Canada for devices that are on the List of medical …

https://publications.gc.ca/collections/collection_2021/sc-hc/H14-353-2021-eng.pdf

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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 …

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

Category: Food, Medical Show Health

Incident reporting for medical devices: Guidance document

(2 days ago) WEBIncident reporting for medical devices: Guidance document. Effective Date: June 23, 2021 Supersedes: October 3, 2011 Health Canada is responsible for helping Canadians …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-310-2021-eng.pdf

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Health Canada Guidance on License Application Types

(5 days ago) WEBJul 23, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device …

https://www.regdesk.co/health-canada-guidance-on-license-application-types/

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Regulations Amending the Medical Devices Regulations (Medical …

(2 days ago) WEBIssues: The nature and duration of public health emergencies can be unpredictable and can affect medical device supply chains.Existing authorities under …

https://gazette.gc.ca/rp-pr/p2/2024/2024-01-03/html/sor-dors277-eng.html

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The Medical Devices Special Access Program in Canada: A Scoping …

(9 days ago) WEBAbstract. New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian …

https://ncbi.nlm.nih.gov/pmc/articles/PMC5863869/

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Canadian regulators issue new reporting requirements for medical …

(9 days ago) WEBDecember 5, 2021. Health Canada, the Canadian medical device market regulator, has published new guidance covering procedures and criteria for medical device …

https://www.emergobyul.com/news/canadian-regulators-issue-new-reporting-requirements-medical-device-shortages

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

(6 days ago) WEBMedical Devices Regulations. SOR/98-282. FOOD AND DRUGS ACT. Registration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His Excellency the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html

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All courses training-formation

(9 days ago) WEBThe intent of the e-learning course, Understanding How Medical Devices are Regulated in Canada – Medical Device Establishment Licensing and Post-market Regulation, is to …

https://training-formation.phac-aspc.gc.ca/course/index.php?categoryid=42⟨=en

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