Register your medical device with Health Canada.
Looking to sell medical devices in Canada? Registrar Corp’s team of regulatory specialists will help you comply with additional classification, licensing, and registration regulations so you can enter the Canadian market safely.
Health Canada Medical Device Licensing
Health Canada reviews and assesses all medical devices for safety, effectiveness, and quality before they can be sold on the Canadian market. Any establishment producing and distributing devices for the Canadian market must:
Classify devices into one of four risk-based categories (Class I, Class II, Class III, or Class IV) based on established criteria and rules
Apply for a Medical Device Establishment License (MDEL) and/or a Medical Device License (MDL) issued by Health Canada based on device classification
Complete Health Canada registration by regularly renewing and updating MDEL or MDL licenses
Registrar Corp will work with you to accurately identify your product’s classification, support you through seeking licensure, and assist with license changes, fees, and more.
Registrar Corp, your personal Regulatory Correspondent.
We’re committed to making your Health Canada registration process quick and easy. Our Health Canada registration and compliance services include:
- Medical device classification assistance
- MDEL application support
- Annual MDEL license renewal
- License update submissions for any device changes
- Health Canada licensing fee facilitation
Get help with Health Canada Medical Device Licenses.
Simply complete the form to get started.