Health Canada Bpa Medical Devices

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Bis (2-ethyhexyl) phthalate (DEHP) and Bisphenol A …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/2-ethyhexyl-phthalate-bisphenol-questions-answers-medical-devices.html

On September 1, 2008 Health Canada will be sending out a survey to ALL manufacturers of licensed Class II, III and IV medical devices. In this survey the manufacturer will only be asked to check a box as to whether their devices contain ≥0.1% …

Guidance on how to complete the application for a new …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence/definitions.html

BPA is mainly used as a raw material in the production of polycarbonates and epoxy resins. BPA or BPA-based polymers are used in the manufacture of a variety of medical …

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, …

Bisphenol A (BPA) - Canada.ca

https://www.canada.ca/en/health-canada/services/home-garden-safety/bisphenol-bpa.html

Guidance Document: Guidance on supporting evidence …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-supporting-evidence-provided-new-amended-licence-applications-class-class-medical-devices-including-vitro-diagnostic.html

Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices was developed by …

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 …

Guidance on how to complete the …

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

Medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical …

Frequently Asked Questions - Medical Devices Regulations

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class IV …

Di(2-ethylhexyl)phthalate and Bisphenol A Testing for …

https://www.intertek.com/green/dehp-and-bpa-testing/

Intertek, a global leader in restricted materials compliance, provides di (2-ethylhexyl)phthalate (DEHP) testing and bisphenol A (BPA) testing for the purposes of …

Blood Pressure Devices – Hypertension …

https://hypertension.ca/bpdevices

Automated blood pressure monitors may not work properly in those with an irregular heart rhythm. If you have an irregular heart rhythm, alert the sales staff so you can test out the …

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