To sell or distribute medical devices in Canada, manufacturers must comply with Health Canada’s Medical Devices Regulations. This includes proper device classification, obtaining a Medical Device Licence (MDL) or Medical Device Establishment Licence (MDEL), and ensuring full compliance with quality and labeling requirements.
At TianHeng Consulting Inc., we assist our clients in obtaining the necessary licenses and registrations, helping you bring medical devices to the Canadian market legally and efficiently.
✅ Our Services Include:
📋 Device Classification & Regulatory Pathway
- Determine the correct device class (Class I–IV)
- Define licensing requirements (MDL vs. MDEL)
- Evaluate equivalency and predicate devices
📝 Medical Device Licence (MDL) Application (Class II–IV)
- Guidance on safety, efficacy, and clinical evidence
- Prepare and submit MDL application to Health Canada
- Coordinate device labeling and instructions for use (IFU)
🏢 Medical Device Establishment Licence (MDEL)
- Required for importers and distributors (including Class I)
- Assist in MDEL application and quality system documentation
- Prepare for potential Health Canada inspections
🧾 Labeling & Bilingual Requirements
- Ensure compliance with Canadian bilingual (English/French) labeling laws
- Assist with device packaging, instructions, and marketing claims review
🔄 Our Process
- Initial Consultation
Understand your product, business model, and compliance goals. - Regulatory Assessment
Confirm classification and licensing route. - Documentation & Application
Compile required dossiers and submit to Health Canada. - Ongoing Compliance Support
Annual licence renewal, inspections, and change notifications.
📞 Contact Us
Get your medical devices licensed and ready for sale in Canada.
📧 info@tianhengconsulting.com ｜ 📞 +1-613-220-8490