Canada Investigational Medical Device

Applications for Medical Device Investigational Testing …

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

2.1 Abbreviations and definitions. 2.1.1 Abbreviations. CTA. Clinical Trial …

Draft Guidance Document: Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html

To provide assistance to manufacturers and importers in preparing the documentation necessary to obtain an authorization for the sale or importation of a medical …

Drug and medical device highlights 2020: Medical …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/medical-devices.html

One of Health Canada's roles is to regulate medical devices that can help Canadians maintain and improve their health. Medical devices are used in the treatment, …

About medical devices - Canada.ca

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

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 Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that the …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The …

Class II – IV Medical Device Investigational …

https://vantagebiotrials.com/class-ii-iv-medical-device-investigational-testing-in-canada/

Canadian Medical Device Classifications The Food and Drugs Act (1) defines a “device” as any article, instrument, apparatus or contrivance, including any component, part …

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, …

Medical Devices Regulations

https://laws-lois.justice.gc.ca/eng/Regulations/SOR-98-282/index.html

69 - PART 2 - Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access 69 - Application 70 - General 71 - Authorization 73 - Additional …

Clinical Research Regulation For Canada | ClinRegs

https://clinregs.niaid.nih.gov/country/canada

As delineated in CAN-23, HC’s Health Products and Food Branch (HPFB) is the national authority that regulates, evaluates, and monitors therapeutic and diagnostic product …