Health Canada Medical Device Classification Rules

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Guidance Document - Guidance on 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-non-vitro-diagnostic.html

Classification rules for IVDDs are discussed in the guidance document, "Guidance for the Risk Based Classification System of In Vitro Diagnostic Devices". The classification of combination products is …

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, …

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

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 …

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

2.2 Classification of IVDDs for use with respect to transmissible agents ("Use with Respect to Transmissible Agents") Rule 1: IVDDs used for donor screening Rule 2: IVDDs used to …

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 …

Guidance documents – Medical devices - Canada.ca

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

They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in Canada. …

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

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

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - Manufacturer’s Obligations; 10 - Safety …

Risk Classification Process for Health Canada Medical …

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 classifications. The …

Health Canada Medical Device Classification - Emergo

https://www.emergobyul.com/services/health-canada-medical-device-classification-consulting

Health Canada device classification. Before medical device and in-vitro diagnostic (IVD) device manufacturers can legally sell their products in Canada, they must comply with Health Canada's medical device …

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