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Fax-back (minor change) application content and classification guidance: Labelling and promotional material

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Chapter 5: Labelling and promotional material

Folder name: 5-LABELLING

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

5.02 Product/package labels

Folder name: 5.02-Product-PackageLabels

IMDRF common content

Samples of the primary and secondary packaging labels.

Notes: 

  1. Do not include shipping labels.
  2. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject nIVD medical device.

IMDRF Health Canada content

  1. All labelling must comply with sections 21 to 23 of the Medical Devices Regulations.
  2. Consult the guidance for the labelling of medical devices, not including in vitro diagnostic devices or the guidance for the labelling of in vitro diagnostic devices as applicable.

Health Canada guidance

Include samples of the primary and secondary packaging labels but exclusive of labels for shipping.

Notes:

  1. All labelling must be provided in English or French, both official languages are to be available upon request.
  2. Labelling for near-patient devices must also be provided in French and English.

Classification

For change to licence/device name: Required

For all other fax-backs (minor changes): Optional

5.03 Package insert/instructions for use

Folder name: 5.03-PackageInsert-InstructionsforUse

IMDRF common content

Package insert/instructions for use included in the package, when required or provide support for why this element is not applicable.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device.

IMDRF Health Canada content

  1. All labelling must comply with sections 21 to 23 of the Medical Devices Regulations.
  2. Consult the guidance for the labelling of medical devices, not including in vitro diagnostic devices or the guidance for the labelling of in vitro diagnostic devices as applicable.
  3. The current version and date of the instructions for use must be stated.

Health Canada guidance

The package insert or instructions for use must be included when required. If this element is not applicable, justification should be provided for its exclusion.

  1. All labelling must be provided in English or French, both official languages are to be available upon request.
  2. Labelling for near-patient devices must also be provided in French and English.
  3. For IVD devices, package inserts must include a summary of the performance specifications, in addition to all other relevant information.

Classification

For all fax-backs (minor changes): Optional

5.04 E-labelling

Folder name: 5.04-e-labelling

IMDRF common content

In addition to the e-labelling itself, the following should be provided:

  1. For eligible medical devices and Software as a Medical Device, the applicant needs to identify which form of e-labelling is being used (for example electronic storage system or built-in system, website)
  2. Details of risk management in relation to e-labelling. If this is part of the overall risk management, refer to it here
  3. When IFUs are requested, a description of the procedure and operations on providing IFU's when requested
  4. Written information for users on the webpage identifying where the IFU and further information can be found in relevant languages
  5. A description on how the e-labelling requirements for the website have been met
  6. If a video/app is available to demonstrate how the device is intended to function, provide a link as well as details about how it is maintained and updated throughout the life cycle of the device

IMDRF Health Canada content

For devices that are not sold to the general public, IFUs may be provided as downloadable from the internet and/or on electronic data storage devices, for example compact disc, digital video disc, USB flash drive, etc. The electronic label or URL must accompany the device at the time of sale and/or delivery and be displayed in a manner that alerts the user to its purpose. A Letter of Attestation must also be included with the application. Refer to the guidance for the labelling of medical devices, not including in vitro diagnostic devices or the guidance for the labelling of in vitro diagnostic devices, for additional information.

If a video/app is available as described in f) above, the video should be available in both French and English.

Classification

For all fax-backs (minor changes): Optional

5.05 Healthcare professional labelling

Folder name: 5.05- HCP Labelling

IMDRF common content

Labelling directed at the healthcare professional other than the package insert, such as the surgical manual.

Classification

For all fax-backs (minor changes): Optional

5.06 Patient labelling

Folder name: 5.06-PatientLabelling

IMDRF common content

Labelling directed at the patient other than the package insert, such as informational material written to be comprehended by the patient or lay caregiver.

Classification

For all Fax-backs (Minor Changes): Optional

5.07 Technical and/or operators manual

Folder name: 5.07-Technical-OperatorManual

IMDRF common content

Labelling directed at the technical users and operators of medical devices focusing on the proper use and maintenance of the device and surgical technique instructions.

Classification

For all fax-backs (minor changes): Optional

5.08 Patient file stickers, cards and implant registration cards

Folder name: 5.08-PatientFileStickersCardsImplantRegistrationCards

IMDRF Health Canada content

  1. If applicable, stickers/cards intended to be place in the patient’s chart identifying the implant (for example serial #, lot #, make, model)
  2. If applicable, implant registration cards

Classification

For all fax-backs (minor changes): Optional

5.09 Product brochures

Folder name: 5.09-ProductBrochures

IMDRF Health Canada content

Draft product brochures available at the time of application

Classification

For all fax-backs (minor changes): Optional

5.10 Other labelling and promotional material

Folder name: 5.10-OtherLabelling-PromotionalMaterial

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Individual jurisdictions may have their own regulations or requirements regarding other labelling elements or advertising and promotional materials. If necessary, this section can be used to address jurisdiction-specific regulations or requirements involving other labelling elements other than those described elsewhere in this section, including advertising and promotional materials.

Health Canada guidance

Include any other relevant labelling or promotional material that does not fit in any other folder.

Classification

For all fax-backs (minor changes): Optional

Page details

2025-11-25