Health Canada Medical Device Labeling Requirements

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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 …

New labelling and MDEL requirements for medical …

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

Under IO No. 1, there was no requirement for importers or distributors of IO-authorized devices to hold a medical device establishment licence (MDEL). Section 2 (2) …

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 been …

Medical devices - Canada.ca

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

Medical devices may also require certification by the Canadian Nuclear Safety Commission (CNSC) prior to licensing for operational or servicing activities. Please visit …

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 …

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

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

32 - Application for a Medical Device Licence 32.1 - Quality Management System Certificate 33 - Foreign Manufacturers 34 - Application for a Medical Device Licence Amendment 35 …

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 …

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 ...

Guidance Document: Labelling of Pharmaceutical Drugs …

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

For drug product lines containing ophthalmic or parenteral drug product formulations, and where two products differ only in the presence or absence of a …

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