Health Canada Guidance Documents Medical Devices

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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 have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a …

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) …

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

Health Canada, along with its international partners in the Global Harmonization Task Force (GHTF), has developed agreements and documents to promote a …

Health Canada and FDA eSTAR pilot: Notice to industry

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

The medical device must not be an in-vitro diagnostic device, a combination product, CBER-led or an FDA dual 510 (k)/CLIA waiver application. You must complete the …

Guidance Documents – Applications and submissions

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section. Guidance documents have been prepared to assist in the interpretation of policies and …

Medical device meetings draft guidance document: …

https://www.canada.ca/en/health-canada/programs/consultation-medical-device-meetings-draft-guidance/guidance-implementation.html

Medical device meetings draft guidance document: Guidance for implementation - Canada.ca Medical device meetings draft guidance document: Guidance for …

Health Canada Issues Final Guidance on …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

The clinical evidence described in the document should be submitted for review as part of either: The medical device license application data …

Open Government Portal - ouvert.canada.ca

https://ouvert.canada.ca/data/dataset?collection=publication&frequency=as_needed&keywords=medical+devices&res_type=publication&keywords=&keywords=naics+code

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for …

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