Health Canada Medical Device Classification System

At Manningham Medical Centre, you can find all the data about Health Canada Medical Device Classification System. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.

Guidance Document - Guidance on the Risk …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html

The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. The safety and effectiveness …

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 …

Classification of health products at the drug-medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/classification-health-products-device-drug-interface.html

The Medical Devices Regulations specify different requirements for products that pose different risks, ranging from lowest (i.e., Class I) to highest risk (i.e., Class IV). The …

Guidance Document: Guidance for the Risk-based …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html

The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. The safety and effectiveness evidence required to support a …

Guidance for the Interpretation of Sections 28 to 31: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html

A device licence application submitted as a SYSTEM, TEST KIT, MEDICAL DEVICE FAMILY, MEDICAL DEVICE GROUP or MEDICAL DEVICE GROUP FAMILY …

Guidance documents – Medical devices - Canada.ca

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

Draft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28] Implementation of Advance Notice of Importation Process for …

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 licence and …

Drug and Medical Device Databases - Canada.ca

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

The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases. These guidelines are designed to facilitate …

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

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

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …