Health Canada Medical Device Regulation

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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 Purposes of Implementing the General Council Decision. 43.2 - Application. 43.3 - …

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

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Medical devices - Canada.ca

(Just Now) WEBThe term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

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

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Guidance documents – Medical devices - Canada.ca

(3 days ago) WEBGuidance documents – Medical devices. Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and …

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

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

(2 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. …

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

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

(2 days ago) WEBMedical Devices Regulations (SOR/98-282) Full Documents available for previous versions. 2024. From 2024-01-03 to 2024-06-20; Consolidated Regulations; Annual …

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

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Regulations Amending the Medical Devices Regulations (Medical …

(2 days ago) WEBThe Notice of Intent for the COVID-19 Medical Devices Regulations that was posted for public consultation on May 2, 2022, for 21 days, informed the …

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

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Guidance on how to complete the application for a new …

(2 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and. improve their health. We assess the safety of drugs and many consumer …

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

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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBThe Medical Devices Regulations (Regulations) use a risk-based approach to regulating products within their scope. The safety and effectiveness evidence requirements are …

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

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Frequently Asked Questions - Medical Devices Regulations - Canada

(8 days ago) WEBThe purpose of the Medical Devices Regulations is to help protect the health and safety of Canadians with respect to the sale of medical devices. The term 'medical device' …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

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Health Canada medical device regulations Gowling WLG

(9 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 event monitoring systems were severely …

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

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Regulations and standards - Canada

(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

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Chapter 6—Regulating Medical Devices—Health Canada

(4 days ago) WEBDevices such as dialysis equipment, pacemakers, and surgical lasers have improved or saved the lives of many Canadians and are indispensable to today’s health care …

https://publications.gc.ca/collections/collection_2011/bvg-oag/FA1-10-2011-6-eng.pdf

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Medical Devices - Canada.ca

(6 days ago) WEBMedical Devices. Health Canada applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/medical-devices-legislation-guidelines.html

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

(Just Now) WEBRegistration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His Excellency the Governor General in Council, on the recommendation of the Minister of …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-1.html

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Overview of medical device regulations in Canada

(3 days ago) WEBOverview of medical device regulations in Canada. By Hasnaa Fatehi 07/02/24. Despite being a relatively small jurisdiction, Canada’s Medical Device …

https://www.regulatoryrapporteur.org/medical-devices/overview-of-medical-device-regulations-in-canada/535.article

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Medical Devices Regulations, SOR/98-282 - CanLII

(2 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. …

https://www.canlii.org/en/ca/laws/regu/sor-98-282/latest/sor-98-282.html

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(5 days ago) WEB32.6 (1) The Minister may cease to recognize a person as a registrar without giving the registrar an opportunity to be heard if it is necessary to do so to prevent injury to the …

https://laws.justice.gc.ca/eng/regulations/sor-98-282/page-3.html

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

(4 days ago) WEB63.1 Sections 63.2, 64 and 65 do not apply to a manufacturer or importer of a medical device unless the device is likely to cause injury to the health of a patient, user or other …

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

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Medical Devices Directorate – Health Canada - Canada.ca

(7 days ago) WEBThe Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that …

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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Proposed Changes to the Guidance on Recognized Standards for …

(8 days ago) WEBHealth Canada updates the list of recognized standards for medical devices periodically in collaboration with its international counterparts and agencies, including …

https://www.jdsupra.com/legalnews/proposed-changes-to-the-guidance-on-8338629/

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What's new: Medical devices - Canada.ca

(9 days ago) WEBMedical Devices Directorate Performance Quarterly Report for Q3 2022-2023. Consultation period extended until April 26, 2023 for proposed agile regulations and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

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

(Just Now) WEB2 These Regulations apply to. (a) the sale and advertising for sale of a medical device; and. (b) the importation of a medical device for sale or for use on individuals, other than …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html

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Proposed Changes To The Guidance On Recognized Standards For …

(5 days ago) WEBThe Regulatory Framework for Licensing Medical Devices. All medical devices must meet certain safety, effectiveness, and labelling requirements under the …

https://www.mondaq.com/canada/healthcare/1520162/proposed-changes-to-the-guidance-on-recognized-standards-for-medical-devices-in-canada

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

(8 days ago) WEBFederal laws of Canada. RELATED PROVISIONS — SOR/2003-173, s. 6. 6 The manufacturer of a medical device for which a medical device licence has been issued …

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

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