Medical Device Labeling Health Canada

Listing Websites about Medical Device Labeling Health Canada

Guidance Document: Guidance for the Labelling of Medical …

(4 days ago) 1.1 Policy ObjectiveTo assist manufacturers of non-in vitro diagnostic devices in complying with the labelling requirements under sections 21 - 23 of t… See more

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

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New labelling and MDEL requirements for medical devices …

(4 days ago) WEBIO No. 2 permits Health Canada to continue to issue expedited authorizations for the sale or import of medical devices in order to accelerate access to certain …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/requirements-medical-devices-interim-order-september-2021.html

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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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Frequently Asked Questions - Medical Devices Regulations

(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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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBGuidance on clinical evidence requirements for medical devices ii Health Canada is the federal department responsible for helping the people of Canada maintain and improve …

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

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Guidance Document

(4 days ago) WEBUse the intended use statement and product labelling (e.g. instructions for use/user manual, marketing materials, website) to verify that the software meets the SaMD

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-291-1-2019-eng.pdf

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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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Regulatory requirements for importing medical devices - Canada.ca

(8 days ago) WEBFor more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

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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 …

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

(5 days ago) WEBMedical devices with cosmetic indications for use are subject to the same stringent Health Canada review as other devices to ensure the benefits outweigh the …

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

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Guidance on how to interpret ‘significant change’ of a medical …

(1 days ago) WEBGuidance on the regulation of medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivative (s) Box 2 concerns …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device/types-changes.html

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Health Canada drafts guidance on electronic media in labeling

(9 days ago) WEBHealth Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile …

https://www.raps.org/news-and-articles/news-articles/2021/3/health-canada-drafts-guidance-on-electronic-media

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Guidance Document: Labelling of Pharmaceutical Drugs for …

(6 days ago) WEBAdherence to this guidance is expected to support the safe and effective use of drugs by health care professionals, patients and consumers. The guidance document reflects …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

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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 Guidance on Medical Devices RegDesk

(5 days ago) WEBHealth Canada Labelling Requirements for COVID-19 Medical Devices. The interim order issued by Health Canada also includes detailed labeling …

https://www.regdesk.co/health-canada-guidance-on-medical-devices/

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Health Canada's labeling guidance, IVD, medical devices, HC

(3 days ago) WEBHealth Canada’s Final Labeling Guidance for IVDs – Decode the Guidelines. May 10, 2016. After a prolonged duration of 18 years, IVD (In vitro …

https://www.freyrsolutions.com/blog/health-canadas-labeling-guidance-ivds

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Packaging and labelling requirements - ic

(2 days ago) WEBIf you sell a prepackaged non-food product in Canada, you must ensure the package label meets the requirements of the Consumer Packaging and Labelling (for example, …

https://competition-bureau.canada.ca/labelling/prepackaged-non-food-consumer-products/packaging-and-labelling-requirements

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Review and Assessment of Existing and Future Techniques for

(1 days ago) WEBAll the labelling requirements are detailed in MDRs, including the symbols to be used in the labelling of medical devices and their packaging, the trade name and …

https://www.mdpi.com/2073-4360/16/10/1343

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