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

Drug/Medical Device Combination Products. 1. Purpose. The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient submission processing system, while …

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

The following types of combination products were classified by the Therapeutic Products Classification Committee in accordance with the Policy on Drug/Medical Device …

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 classification of drug-medical device combination products, which combine at least one device component and one drug component, is outside the scope …

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

For questions about the classification of products at the drug-medical device interface or the regulatory framework that may apply to a particular health product, please contact 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

Policies - Canada.ca

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

Policies. These policies are an interpretation of the purpose and intent of the Food and Drugs Act and Medical Devices Regulations. Classification of products for …

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 …

Drug-Device Combination Products under MDR | BSI …

https://www.bsigroup.com/en-CA/Medical-Devices/Technologies/drug-device-combination-products/

Introduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the …

Drug and Medical Device Combination Product …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/combo_mixte_dec_pol-eng.pdf

Classification Committee in accordance with the Policy on Drug/Medical Device Combination Products, October 20, 1998. This list also included products which are …

Combination Products | FDA - U.S. Food and Drug …

https://www.fda.gov/combination-products

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