Class IV IVD 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.
On this page
- Chapter 5: Labelling and promotional material
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 and package labels
Folder name: 5.02-Product-PackageLabels
IMDRF common content
Samples of the primary and secondary packaging labels.
Notes:
- Do not include shipping labels.
- The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject IVD medical device.
IMDRF Health Canada content
All labelling must comply with sections 21 to 23 of the Medical Devices Regulations.
Consult the guidance for the labelling of 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.
Indicate in the labelling if the labelling material covers components or devices not currently licensed in Canada.
Classification
New licence applications: Required
Amendment licence applications: Conditionally required – If applicable to the amendment.
5.03 Package insert and 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 IVD medical device.
IMDRF Health Canada content
- All labelling must comply with sections 21 to 23 of the Medical Devices Regulations.
- Consult the guidance for the labelling of in vitro diagnostic devices.
- Package inserts must include all relevant information, including a summary of the performance characteristics.
- The current version and date of the instructions for use must be stated.
Classification
New licence applications: Required
Amendment licence applications: Conditionally required – If applicable to the amendment.
Health Canada guidance
For amendments or new license applications for devices based on previously licensed devices, provide red-line versions comparing the current IFU to the IFU of the last submission. Clearly document the revision history, indicating all revisions made.
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:
- For eligible IVD 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)
- Details of risk management in relation to e-labelling. If this is part of the overall risk management, refer to it here
- When IFUs are requested, a description of the procedure and operations on providing these IFUs
- Written information for users on the web page identifying where the IFU and further information can be found in relevant languages
- A description on how the e-labelling requirements for the website have been met
- If a video/app is available to demonstrate how the test is intended to perform and be interpreted, 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 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 Patient labelling
Folder name: 5.05-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
5.06 Technical and/or operators manual
Folder name: 5.06-Technical-OperatorManual
IMDRF common content
Labelling directed to the technical users and operators of IVD medical devices focusing on the proper use and maintenance of the IVD medical device.
Classification
New and amendment applications: Conditionally required – If applicable for the device
5.07 Product brochures
Folder name: 5.07-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
5.08 Other labelling and promotional material
Folder name: 5.08-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