On April 1, 2026, the HC of Canada has published a guide explaining the procedures and submission requirements that companies intending to sell Private Label Medical Devices must follow when applying for or amending a Medical Device License (MDL).
The Private Label Medical devices have the following characteristics.
1) identical in every respect to a medical device manufactured by an original manufacturer and licensed by Health Canada and
2) labelled with the private label manufacturer's name, address and product name and identifier
This guidance describes how to complete an application for a new medical device licence or an amendment for a Class II, III or IV private label medical device.
As the private label manufacturer, you may submit an application for a new medical device licence (MDL) for a private label medical device only after an MDL has been issued to the original manufacturer.
To add new identifiers (for example, catalogue numbers) to an existing private medical device licence, you may submit an amendment only after Health Canada has licensed the corresponding identifiers for the original manufacturer's medical device.
To apply for a new device licence or medical device licence amendment, you must complete and submit an application through the Regulatory Enrolment Process (REP). This process facilitates the filing and processing of regulatory information. REP uses XML files generated by web-based templates instead of PDF forms. Templates and forms are used to capture the necessary information related to company, dossier, transaction and application information.
Please refer to the link below.
Guidance on how to complete the application for a new medical device licence or amendment for a private label medical device - C
Guidance on how to complete the application for a new medical device licence or amendment for a private label medical device Effective date: April 01, 2026 Document change log Date Changes June 1, 2005 General updates April 1, 2011 General updates April 1,
www.canada.ca
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