Health Canada Drug Medical Device Combination Products

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Drug/Medical Device Combination Products - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/drug-medical-device-combination-products.html

The drug component of a combination product must comply with the Food and Drug Regulations and the device component must comply with the Medical Devices Regulations. The Therapeutic Products Directorate ( TPD ) and the Biologics Genetic Therapies …

Policy on Drug/Medical Device Combination Products

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html

A combination product will be subject to either the Medical Devices Regulations or the Food and Drug Regulations according to the principal mechanism of action by …

Consultation on the Issue identification paper: Drug …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft.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 …

Issue identification paper: Drug-device combination …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft/document.html

1. Classifying drug-device combination products. The Policy uses the term "combination product" to describe a drug-device combination product. However, this …

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

The definitions of "device" and "drug" in the F&DA provide the basis for Health Canada's classification of these two product lines (i.e., device and drug). Health …

Drug and medical device highlights 2019: …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2019.html

Health Canada Drugs for human use Drugs for human use: 2019 in brief Safe, effective and high quality drugs can help Canadians maintain and improve their health. These include …

Drugs and health products - Canada.ca

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

Health Canada is not a manufacturer or distributor of drugs and health products. We are the federal regulator. For additional drug information related to treatment options or …

Frequently Asked Questions About Combination …

https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products

Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the primary mode of …

Combination Products Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents

New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products - 12/2009 Devices Used to Process Human Cells, …

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