ANSWERED ON THIS PAGE:
- How does Health Canada classify IVDs?
- Which license type is required in Canada for in vitro diagnostic devices?
- What is the QMS requirement for IVD registration in Canada?
Importance of Health Canada's IVD classification system
If you're interested in selling in vitro diagnostic (IVD) devices in Canada, you must first register and obtain the proper license from Health Canada.
As is the case with medical devices, your IVD's classification determines the required license type. Health Canada has a four-tier, risk-based classification system (Class I, II, III, and IV) for IVD products under its jurisdiction.
IVD classifications in Canada are determined using a set of nine rules. How your IVD is classified further determines which type of license your product requires as well as which quality management system (QMS) requirements apply to your device.
Medical device licensing for IVDs in Canada
A Medical Device License (MDL) is required for Class II, III or IV IVD devices before they can be sold in Canada. The device manufacturer must apply for the MDL. Health Canada MDL submissions require the manufacturer to submit data to Health Canada (Class III/IV), or attest to possessing data (Class II), that supports the safety and performance of the device.
An MDL is not required for Class I devices. If you have a Class I IVD and intend to sell it directly to consumers (rather than through distributors), you need a Medical Device Establishment License (MDEL).
Canada IVD quality management system requirements
Manufacturers of Class II-IV IVD devices must be certified to the ISO 13485 standard for quality management systems under the Medical Device Single Audit Program (MDSAP), which complies with additional quality system requirements of the Canadian Medical Devices Regulations (CMDR). As part of your IVD MDL application process, Emergo can support the implementation of a compliant ISO 13485 quality management system under MDSAP or update your existing system to meet Health Canada requirements.
IVD classification consulting with Emergo by UL
How understanding IVD classification system helps with device registration
With consultants across Canada, Emergo has years of experience helping IVD companies register their products with Health Canada. Our IVD registration services include:
- Identifying the classification of your IVD device under the Health Canada system
- Determining applicable Health Canada fees
- Compiling your MDL or MDEL application and submitting it to Health Canada
- Adapting your existing ISO 13485 quality system to meet MDSAP and CMDR requirements
- Conducting customized on-site training for ISO 13485, MDSAP and CMDR compliance
We also help companies with IVD CE certifications in Europe and other markets.
Canadian IVD classification FAQs
How long does it take to secure an MDL for an IVD in Canada?
The time required to secure your MDL depends on your device classification. Download our Canada IVD process chart for estimated timeframes by device classification.
What should we include in our Health Canada MDL submission?
The requirements for your IVD Medical Device License application depend on your device classification. However, the submission documentation for a Class III or IV IVD is similar to a US FDA 510(k) or EU Technical File, with some key differences. Get more information about MDL submission requirements in our free 17-page white paper: Preparing a Canada MDL Application.
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