Dossier ID request form for medical devices

Dossier InformationFootnote 1

Device Class (required)Footnote 3
Regulatory Activity Type (required) Footnote 4

Licence Application Type (required)Footnote 7

Primary Contact Information (required)Footnote 8

Language of Correspondence (required)

Alternate Contact Information (optional)Footnote 9

Language of Correspondence

Clicking 'Submit' will send the completed form to Health Canada. If you do not see a 'Thank you' page after clicking 'Submit', then go 'back' to the page and try submitting again. If the issue persists, please contact

Help Text

Footnote 1

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

A request for a dossier ID should only be placed a maximum of eight weeks prior to filing a regulatory transaction.

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Footnote 2

Company and Contact IDs must be obtained from the final Company XML file, issued by Health Canada.

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Footnote 3

Device Class: .

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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

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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' if the Regulatory Activity Type is 'Licence'.

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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.

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Footnote 7

Licence Application Type:

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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.

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Footnote 9

Sponsors may choose to provide an alternate contact, however this is not a requirement.

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