Health Canada Medical Device Risk Classification

Guidance Document - Guidance on the …

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

Once confirmed, the classification rules should be applied to determine its proper risk classification. The rules for non-IVDD medical devices can be grouped into four sets: Invasive …

Risk classification guide for medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079.html

Risk classification guide for medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079/document.html

During an inspection, the inspector will assign a risk classification to each observation, ranging from 1 for higher risk issues to 3 for lower risk issues. The three levels of risk …

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 …

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 for Industry- Keyword Index to Assist

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

The purpose of the Medical Device Keyword Index is to assist manufacturers in verifying the classification of medical device products after application of the Classification Rules for …

Medical devices for uses related to COVID-19 - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/about.html

These classifications determine the path a manufacturer or importer can follow to bring to market in Canada their medical device for use related to COVID-19. Expedited …

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

Classification is the first step in the review of health products by the Health Products and Food Branch (HPFB). When the classification of a health product is not evident, the …

Risk Classification Process for Health …

https://medicaldeviceacademy.com/health-canada-vs-european-class-rules/

There are four European and Canadian medical device classifications. Class I, IIa, IIb, and III are the European classifications, while Class I, II, III, and IV are the Canadian …

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

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

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 …