Companies interested in commercializing their in vitro diagnostic (IVD) devices in Canada must first register and obtain proper license from Health Canada.
As is the case with medical devices, which license to apply for depends on the classification of your IVD device. Health Canada has a four-tier, risk-based classification system (Class I, II, III and IV) for IVD products under its jurisdiction.
Health Canada license requirements for IVD devices
Class I IVD manufacturers intending to sell their products directly to consumers rather than through distributors in Canada are required to secure a Medical Device Establishment License (MDEL).
Manufacturers of Class II, III and IV IVD devices must hold ISO 13485 standard for quality management systems, and also with additional quality system requirements of the Canadian Medical Device Regulations (CMDR). As part of your IVD MDL application process, Emergo can fully support implementation of a fully compliant ISO 13485 quality management system, or update your existing system to meet Health Canada requirements.
How Emergo can help you obtain Canadian IVD approval
With offices in BC and Ontario, Emergo has years of experience helping IVD companies register their products with Health Canada. Our registration services include:
- Identifying classification of your IVD device under the Health Canada system
- Determining applicable Health Canada fees
- Compiling your MDEL or MDEL application and submitting it to Health Canada
- Adapting your existing ISO 13485 quality system to meet CMDR requirements
- Conducting customized on-site training for ISO 13485 and CMDR compliance
We also help companies register their IVD devices in Europe and other markets.
Please contact us to learn more about our Canadian IVD registration services.