Dossier ID Request Form for Medical Devices
- Footnote 1
If you already have a dossier ID, you do not need send a draft dossier XML file. You can proceed with your transaction by completing the RT XML template. The Dossier ID should be known from previously issued acknowledgment letter and the format should be HC6-024-x######. If you are unsure what your dossier ID is contact Health Canada at firstname.lastname@example.org.
- Footnote 2
Company and Contact IDs must be obtained from the final Company XML file, issued by Health Canada.
- Footnote 3
- Footnote 4
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
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' is the Regulatory Activity Type is 'Licence'.
- Footnote 6
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
Licence Application Type: Placeholder for MDSAP Guidance
- Footnote 8
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
Sponsors may choose to provide an alternate contact, however this is not a requirement.
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