ANSWERED ON THIS PAGE:
- Which medical devices require a Canada Medical Device Establishment Licence?
- Which medical devices require a Canada Medical Device Licence?
- What are the QMS requirements for each licence type?
If you are planning on selling medical devices in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada with different requirements.
Health Canada Medical Device Establishment License (MDEL)
If you manufacture Class I medical devices or In Vitro diagnostic devices (IVDs) and plan to sell directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL). If you choose to sell through distributors in Canada, your distributor is required to have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications. If the devices are Class II - IV, the manufacturer must hold a medical device license as well in order to be sold in Canada even if sold under an MDEL.
Health Canada Medical Device License (MDL)
A Canadian Medical Device License (MDL) is required for companies selling Class II - IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.
Obtaining an MDL is comparable to the US FDA 510(k) process. The process of securing an MDL is usually faster than that a 510(k) for Class II devices, about the same for Class III devices, and more lengthy for Class IV devices.
Health Canada medical device and quality management system requirements.
When applying for an MDL, you will also need to prove that you have a certified ISO 13485 quality management system under the Medical Device Single Audit Program (MDSAP), which meets the specific requirements of the Canadian Medical Devices Regulations (CMDR). You can read more about ISO 13485 for Canada here.
How Emergo can help with Health Canada medical device approval
With consultants across Canada, Emergo has experience helping 100+ medical device and IVD companies enter the Canadian market. Our services include:
- Confirming your device classification in Canada.
- Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf. Emergo can also act your regulatory correspondent with Health Canada for your MDL.
- Developing, implementing, or modifying your ISO 13485 quality management system to meet MDSAP and Canadian requirements.
- Providing onsite employee training on ISO 13485, MDSAP, and Canadian Medical Devices Regulations (CMDR).
- Determining the proper annual license fee payable to Health Canada.
- Providing onsite auditing to confirm compliance with ISO 13485, MDSAP, and CMDR.
Contact us for more information on our Health Canada medical device registration services.
Common MDL and MDEL registration questions
My device has FDA clearance – is there a fast-track for devices sold in other major markets?
Health Canada does not recognize approvals in other countries and they do not give you an significant advantage in the approval process. However, a rejection of an application in another jurisdiction may adversely affect an approval in Canada.
Much of the information required for Health Canada submissions is the same as that of an EU technical file or US 510(k), so having these could potentially reduce preparation time.
Do foreign manufacturers need in-country representation in Canada?
No. In-country representation is not required by Health Canada for medical devices. Foreign manufacturers may submit device registration applications and hold the registration.