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Class III nIVD applications content and classification guidance: Labelling and promotional material

IMDRF common content and IMDRF Health Canada content may contain minor formatting or editorial edits compared to the source material. These changes were made to conform with the Government of Canada’s guidelines for web content.

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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.

Health Canada guidance

While draft labelling may be provided initially in the licence application, final labelling will be required before a licence is issued.

The statements of indications for use and/or intended use must be clearly stated in the device labelling, and will be the official claims against which authorization will be assessed. All expressed or implied claims made elsewhere in the labelling (such as instructions of use, advertising, or promotional material) must be consistent with the official statement.

Labelling materials should include, as appropriate, recommended disposal techniques, the nature of combustion products the risk of explosion, etc.

Devices sold in non-sterile condition, but intended to be used sterilized, must specify the recommended sterilization process in the labelling.

If the labelling material covers components or devices not currently licensed in Canada this should be identified in the labelling.

Classification

New and amendment applications: Required

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.
  3. The current version and date of the instructions for use must be stated.

Classification

New and amendment applications: Required

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, identification of 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 IFUs 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-labeling requirements for the website have been met
  6. If a video/app is available to demonstrate how the device is intended to function, 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, 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

New and amendment applications: Optional

5.05 Health care professional labelling

Folder name: 5.05-HealthcareProfessionalLabelling

IMDRF common content

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

Classification

New and amendment applications: Conditionally required – If applicable for the device

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

New and amendment applications: Conditionally required – If applicable for the device

5.07 Technical and/or operators manual

Folder name: 5.07-Technical-OperatorManual

IMDRF common content

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

Classification

New and amendment applications: Conditionally required – If applicable for the device

5.08 Patient file stickers, cards, and implant registration cards

Folder name: 5.08-PatientFileStickers-Cards-ImplantRegistrationCards

IMDRF Health Canada content

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

Health Canada guidance

This section applies to implants as defined in Schedule 2 of the Medical Devices Regulations:

If the subject device requires an implant registration system, the manufacturer must comply with Sections 66 to 68 of the Regulations. In the submission, the manufacturer is to provide samples of the implant registration cards, which must meet the requirements outlined in Section 66.

Classification

New and amendment applications: Conditionally required – If applicable for the device

5.09 Product brochures

Folder name: 5.09-ProductBrochures

IMDRF Health Canada content

Draft product brochures available at the time of application.

Classification

New and amendment applications: Conditionally required – If applicable for the device

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

New and amendment applications: Conditionally required – When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this chapter.

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2025-11-25