Medical Devices Bureau Health Canada

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Medical Devices Directorate – Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

The Directorate consists of 6 offices and bureaus: 1. Director General’s Office 2. Bureau of Licensing Services 3. Bureau of Investigation Testing Authorization, Special Access Program and Post-Market Surveillance 4. Bureau of Evaluation 5. Bureau of Planning and Operations 6. Bureau of Policy and Internation… See more

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, diagnosis …

Medical Devices Active Licence Listing (MDALL)

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

The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

About medical devices - Canada.ca

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

In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the …

Pharmaceutical Drugs Directorate - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/therapeutic-products-directorate.html

Bureau of Medical Sciences. ... For general enquiries for medical devices, please visit Medical Devices Directorate (MDD) Bureaus. Bureau of Cardiology, Allergy and …

Marketed Health Products Directorate - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/marketed-health-products-directorate.html

Health Canada's Marketed Health Products Directorate monitors and assesses the safety and effectiveness of authorized health products that come onto the market in Canada. …

Applications for Medical Device …

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

The Medical Devices Bureau is responsible for administering the requirements within Part 3 of the Medical Devices Regulations (herein referred to as the Regulations) that govern the …

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/guidance-document.html

For guidance on a specific device, please contact the Medical Devices Bureau to schedule a pre-submission meeting by email at meddevices …

Canada - Healthcare and Medical Equipment | Privacy …

https://www.privacyshield.gov/article?id=Canada-Healthcare-andMedical-Equipment

Medical devices are regulated federally by Health Canada’s Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada’s Food and Drugs Act …

Health Canada's Medical Device Bureau Completes Evaluation of …

https://www.yahoo.com/entertainment/news/health-canadas-medical-device-bureau-131500521.html

Solos Endoscopy, Inc. , a provider of quality innovative healthcare instruments to hospitals across the United States, is pleased to announce that Health …

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