Guidance on Private Label Medical Devices – Health Canada Overview

Purpose and Scope

This guidance document outlines Health Canada’s regulatory expectations for private label medical devices (also known as rebranded or OEM-labelled devices). Private label devices are identical in design, materials, manufacturing process, and performance to the original licensed device but are marketed under the private label company’s name and branding. The document clarifies when the private label company must hold its own medical device licence and establishment licence to import, distribute, or sell the device in Canada. Guidance Document: Private Label Medical Devices - Canada.ca

Key Definitions

• Private Label Device: A medical device that is identical to an already licensed device but sold under the private label company’s brand name.
• Original Manufacturer: The company that holds the original medical device licence and is responsible for design, manufacturing, and quality control.
• Private Label Company: The entity that markets the device under its own brand without altering the device.

Regulatory Obligations

Establishment Licence

• The private label company must hold a valid Medical Device Establishment Licence (MDEL) if it imports, distributes, or sells Class II, III, or IV devices.
• An MDEL is required regardless of whether the device is licensed under the original manufacturer or under the private label.

Device Licence

• General Rule: The private label company must obtain its own medical device licence unless the original manufacturer’s licence explicitly covers the private label branding and intended use.
• Exception: No separate device licence is required if:
  • The device is identical (no changes in design, materials, or performance specifications).
  • The labelling complies with the original approved labelling (except for the private label company’s name, address, and branding elements).
  • The intended use remains the same as approved for the original device.
  • The original manufacturer agrees to the private labelling arrangement and maintains responsibility for quality and post-market obligations.

Documentation and Agreements

Private label arrangements typically require:

• A written agreement between the original manufacturer and the private label company outlining responsibilities.
• Confirmation that the device meets the same specifications as the licensed version.
• Evidence that labelling changes are limited to branding and do not affect safety or performance.

Practical Considerations

• Private label companies should verify with the original manufacturer whether their specific branding is covered under the existing licence.
• Changes to labelling that imply different performance, indications, or contraindications require a new licence application.
• Both parties must maintain compliance with quality management system requirements (ISO 13485 or equivalent).
• Post-market responsibilities (e.g., mandatory problem reporting, recalls) remain with the licence holder unless otherwise agreed and approved by Health Canada.

Implications for Compliance

• Failure to hold required licences can result in enforcement actions, including product seizure or administrative penalties.
• Private label companies should maintain records demonstrating the device’s equivalence to the licensed version.

This guidance ensures that private label medical devices meet the same regulatory standards as originally licensed devices, protecting public health while allowing commercial flexibility. Detailed scenarios, licence application considerations, and contact information are provided in the official Health Canada private label guidance document. Guidance Document: Private Label Medical Devices - Canada.ca