Health Canada Medical Device Performance Standards

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Standards - Canada.ca

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

Standards. The following are links to the list of national and international medical device standards recognized by the Therapeutic Products Directorate (TPD) and related information. Unless otherwise indicated, the complete standard, including …

Service Standards for Medical Device Submission …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html

Health Canada posts service standards and performance information for regulatory services ...

Performance standards for the fees in respect of drugs …

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

The standards appropriately reflect the Department's ability to deliver its service (s) within a set timeframe. For the purposes of the Fees in Respect of Drugs and Medical Devices …

Medical devices - Canada.ca

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

Medical devices. 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, …

Guidance Document: Recognition and Use of Standards …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-recognition-use-standards-under-medical-devices-regulations.html

One way to provide such criteria is to make use of standards issued by national or international standards writing organizations. Health Canada believes that conformance …

Management of Applications for Medical Device Licences

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations.html

2.1 Filing of Medical Device Licence Applications; 2.2 Guidance Documents, Policies, and Application Forms; 2.3 Target Performance Standards in Calendar Days; 2.4 …

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

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

62.1 - Assessments Ordered Under Section 21.31 of the Act 62.2 - Activities Ordered Under Section 21.32 of the Act 62.21 - Shortages 63 - Recall 66 - Implant Registration 69 - …

Service standards and performance information for fiscal …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations.html

Service standards and performance information for fiscal year 2020 to 2021 Health Canada As part of its ongoing commitment to provide quality client service, Health …

Consumer Advertising Guidelines for Marketed …

https://adstandards.ca/wp-content/uploads/2020/02/Consumer-Advertising-Guidelines-for-Marketed-Health-Products-2020.pdf

Labelling Standard Category IV Monograph Product Monograph Authorized Labelling Product Licence Product Monograph Authorized LabellingMedical DevicesClass II, e.g. …

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