Understanding Canadian regulation…

Health Canada, a national regulatory body similar to the FDA, issues two kinds of licenses:

Medical Device Establishment License (MDEL)

To sell Class I medical devices and in vitro diagnostic devices in Canada, companies must possess an MDEL. The purpose of this license is to ensure the Inspectorate is made aware of sales activity for these devices, and to ensure license holders have sufficient protocols for documenting transactions, executing recalls, handling complaints, and other essential business practices.

Medical Device License (MDL)

Manufacturers of Class II, III, and IV medical devices require a Canadian Medical Device License (MDL). Unlike the MDEL, the MDL pertains specifically to your product. With professional guidance from Device Portal it is possible to obtain an MDL inside of one month; however, companies should expect to receive most licenses within one to three months from intiatial application.

Organizations applying for a Canadian Medical Device License must verify they are ISO 13485:2003 certified. This quality system satisfies the specific requirements of the Canadian Medical Device Regulations (CMDR). Device Portal can offer assistance with meeting these standards, also referenced as the Canadian Medical Devices Conformity Assessment System (CMDCAS).

The following is a general overviuew of the Health Canada approval process.

Step 1
Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CDMR). All devices will fall into Class I, Class II, Class III or Class IV designations.

Step 2
Health Canada mandates that for all devices (except class I devices) the manufacturer implements ISO 13485:2003 which includes additional specific requirements of the CMDR, that are not required of companies currently selling in the European market. The manufacturers must ensure they update their system incorporate the CMDR requirements.

Step 3
All devices (except Class I) must have the ISO 13485:2003 quality system (re)audited by a Registrar accredited by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). A new ISO 13485 certificate will be issued upon successful completion of the audit.

Step 4
For Class I devices:
A Medical Device Establishment License (MDEL) is only needed if you sell your device directly to the end user. For all other devices, a Canadian Medical Device License (MDL) application is needed for your device. Please note that an MDL application is for the device itself whereas an MDEL is a permit for the distributor/importer, or a manufacturer of Class I devices.

Step 5
For Class I devices:
One needs to submit a MDEL application (if selling directly into Canada or needs to ensure their distributor has a valid certificate) and pay for the Health Canada fees.

For Class II devices:
One needs to submit a MDL application, ISO 13485 certificate and pay for the Health Canada fees.

For Class III and IV devices:
One needs to submit MDL application, ISO 13485 certificate and Premarket Review Document following the Summary Technical Document (STED) (which may include clinical data) and pay the applicable Health Canada Fees.

Step 6
For Class IV devices, Health Canada will review your MDL application and Premarket Review Document. They will then issue a final decision.

Step 7
All approved applications will be posted on the Health Canada website.

Step 8
You will now be allowed to sell your medical device in Canada. Licenses do not expire but you must pay annual fees to Health Canada. Failure to pay fees will result in your approval license being revoked.

Device Portal can complete the Health Canada MDL and MDEL so that you can start selling your devices on the Canadian market. We can help you with:

Device Classification
Determining the proper annual license fee
Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment Licence (MDEL) application.
Develop, implement or modify your ISO 13485:2003 quality management
Provide onsite employee training on ISO 13485:2003 and CMDR.
Provide onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.

Contact us for more information on critical licensing requirements.