Dossier ID request form for medical devices
Help Text
- Footnote 1
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If you already have a dossier ID, there is no need to request a dossier ID . You can proceed with your transaction by completing the RT XML template. The Dossier ID should be known from previously issued letter and the format should be m######. If you are unsure what your dossier ID is contact Health Canada at devicelicensing-homologationinstruments@hc-sc.gc.ca.
A request for a dossier ID should only be placed a maximum of eight weeks prior to filing a regulatory transaction.
- Footnote 2
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Company and Contact IDs must be obtained from the final Company XML file, issued by Health Canada.
- Footnote 3
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Device Class: 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 .
- Footnote 4
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Regulatory Activity Type: Please refer to the Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format
- Footnote 5
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Licence Number: This number is assigned by Health Canada once a device(s) has been authorized for sale. Only input the licence amendment and minor change. Input 'N/A' if the Regulatory Activity Type is 'Licence'.
- Footnote 6
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Name of device, as it appears on the label: Only one name should be entered in this field. The listed name will be used as the licence name unless it is deemed that a generic licence name is more appropriate to cover all of the devices contained within the licence.
- Footnote 7
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Licence Application Type: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html
- Footnote 8
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The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier.
- Footnote 9
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Sponsors may choose to provide an alternate contact, however this is not a requirement.
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