Health Canada Medical Devices Classification

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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

Examples of devices that are classified under this rule are: Nebulizer (direct patient interface) Biopsy suction instrument Infant aspirator (battery-powered) …

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 …

About medical devices - Canada.ca

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

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 …

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 …

Guidance document: Classification of products at the …

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

In most cases, the distinction between devices and drugs is clear and these products can be easily classified according to the definitions. However, as new health …

Health Canada Medical Device …

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

There are four device classifications--Class I, II, III and IV--using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98 …

Classification of products under the Food and Drugs Act …

https://www.canada.ca/en/health-canada/services/drugs-health-products/classification-products-food-drugs-act.html

Classification is the first step in any regulatory process at Health Canada. The Food and Drugs Act (F&DA) and its regulations serve as a basis for the classification of drugs, …

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