Health Canada Medical Device Labeling

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Guidance Document: Guidance for the Labelling of …

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

Each device including a system, medical device group, medical device family, or medical device group family must have a name. The device licence is issued for (a) the device name on the label which may describe one device, (b) an administrative …

Medical devices - Canada.ca

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

The 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, …

Guidance Document - Private Label Medical Devices

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

In order for private label manufacturers to fulfil their medical device application requirements, Health Canada will accept a letter of authorization, written by the …

Guidance documents – Medical devices - Canada.ca

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

Guidance documents – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have …

Medical Devices Regulations ( SOR /98-282) - laws …

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

43.5 - Marking and Labelling 43.6 - Notice to Minister 44 - Establishment Licence 44 - Prohibition 45 - Application 46 - Issuance 46.1 - Annual Review of Licence 47 - Refusal …

Questions and Answers: Plain Language Labelling …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/questions-answers-plain-language-labelling-2019/document.html

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending …

Labelling Requirements Checklist - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling-requirements-checklist.html

Applicants are responsible for ensuring that the label complies with the Labelling and Packaging ...

Canada - Labeling/Marking Requirements - International …

https://www.trade.gov/country-commercial-guides/canada-labelingmarking-requirements

The Canadian Consumer Packaging and Labeling Act requires that all labels be bilingual in English and French, and that the following information appear on the …

Does Health Canada accept symbols in labeling? - Elsmar Cove …

https://elsmar.com/elsmarqualityforum/threads/does-health-canada-accept-symbols-in-labeling.39064/

Section 86 of the Medical Devices Regulations sets out the requirements of a label on a device sold for investigational testing. In addition to the name of the device …

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