Importing medical devices into Canada: MDEL and licences
To import medical devices for sale in Canada, your company generally needs a Health Canada establishment licence (MDEL), and most devices need their own licence too. Here is how to tell what applies before the goods ship.
- CompanyMDEL to import
- Devicelicence for class II–IV
- Riskclass I (low) to IV (high)
Customs rules change — confirm with the official sources on this page or with a licensed customs broker before you ship.
Two ways to get this done
Do it yourself
Everything you need is on this page, step by step, from official government sources.
Read the guideLet a broker handle it
A licensed customs broker can make sure your Health Canada licences are on every entry and clear your devices. Free quote, no commitment.
Get a free quoteIn short
What Health Canada requires
To import medical devices for sale, your company generally needs a Medical Device Establishment Licence (MDEL) with the import activity — for every class of device, Class I included.
Read the details
The device itself needs a Medical Device Licence (MDL) if it is Class II, III or IV. Class I devices, the lowest risk, don’t. You must also confirm that your foreign supplier holds an MDEL when one is required.
Some businesses are exempt, such as retailers selling only to end users for personal use and health care facilities. All requirements must be met at the time of import: Health Canada works with the CBSA and can recommend that non-compliant devices be refused or seized at the border.
Importing medical devices, step by step
Confirm it’s a medical device
Check whether your product meets the definition of a medical device — many health and wellness products do.
Find its risk class
Find the device’s class, from I (lowest risk) to IV (highest). The class decides whether the device needs its own licence.
Get your MDEL
Apply to Health Canada for an MDEL with the import activity, listing the classes of devices you will import — before your first shipment.
Check the device licence
For Class II, III or IV devices, confirm the device has an active licence in Health Canada’s Medical Devices Active Licence Listing.
Check your supplier
Make sure your foreign distributor holds an MDEL when required, unless an exemption applies.
Import and keep records
Import only what your licences cover, and keep distribution and complaint records as your licence requires.
What each class needs
From Health Canada’s requirements for importing medical devices.
- Class I (lowest risk)
- Your MDEL with the import activity; no device licence
- Class II
- Your MDEL + the device’s Medical Device Licence
- Class III
- Your MDEL + the device’s Medical Device Licence
- Class IV (highest risk)
- Your MDEL + the device’s Medical Device Licence
No licence, no entry
Devices that don’t meet the requirements at the time of import can be refused or seized at the border, or ordered removed or destroyed. Check your MDEL and the device licence before the goods leave the supplier.
Common questions
Do I need an MDEL for Class I devices?
Yes, generally — importers of all classes need an MDEL with the import activity unless an exemption applies.
How do I check whether a device is licensed?
Search Health Canada’s Medical Devices Active Licence Listing (MDALL). Establishment licences can be checked in the MDEL listing.
I only sell to consumers in my shop. Do I need an MDEL?
Retailers selling only to end users for personal use are exempt from the MDEL — but the devices themselves must still be properly licensed.
Can a broker help?
Yes. A customs broker can make sure your licence numbers are on every entry and flag shipments Health Canada may stop. Get a broker quote.
Check where you stand
See which import requirements apply to your shipments.
Keep reading
The next steps most people take from here.
Importing
The whole path to importing commercial goods into Canada, in order.
Read →Import/export number (RM)
The import/export account number the CBSA needs before your first shipment.
Read →Import readiness
Check your import readiness: CARM, RPP security, classification, permits.
Read →Get a quote
Describe your shipments and we will connect you with a licensed customs broker.
Read →