Dossier ID request form for medical devices

Pilot participants only

This dossier ID request form is available to medical device regulatory enrolment process pilot participants only. If you are not a pilot participant, please do not complete this form.

Dossier InformationFootnote 1






Class II
Class III
Class IV


Minor Change
Licence
Licence Amendment
Private Label
Private Label Amendment



QMSC must be issued by a Medical Device Single Audit Program (MDSAP) Recognized/Authorized Auditing Organization. Private Label Manufacturers should select 'Not Applicable' as they do not hold their own valid MDSAP Certificate to support their private label licence application(s).




Primary Contact Information (required)Footnote 8





English
French






Alternate Contact Information (optional)Footnote 9





English
French






Clicking 'Submit' will send the completed form to Health Canada and a copy to the email address listed in the 'Primary Contact Information' section. 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 hc.ereview.sc@canada.ca.

Help Text

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 devicelicensing-homologationinstruments@hc-sc.gc.ca.

A request for a dossier ID should only be placed a maximum of four 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: Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs).

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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' is 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: Placeholder for MDSAP Guidance

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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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