The Emergo Group, a consultant group that serves medical device companies in 25 countries worldwide, has released a helpful process chart that illustrates the Health Canada approval process.

From the Emergo website:

To obtain access to the Canadian market, medical device manufacturers will need to secure a license. Health Canada issues two types of licenses: the Health Canada Medical Device Establishment License (MDEL) and the Health Canada Medical Device License (MDL).

The Canadian medical device approval process explained

The chart shown illustrates the Health Canada approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

Step 1

Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CMDR). Devices fall into Class I, Class II, Class III or Class IV.

Step 2

For all devices except Class I, Implement an ISO 13485:2003 quality management system that includes the additional specific requirements of the CMDR. Standard ISO 13485 certification, often used by companies selling in the European market, does not meet Canadian requirements. Updates to the existing procedures or new procedures must be implemented.

Step 3

For all devices except Class I, have ISO 13485:2003 quality system (re)audited by a Registrar accredited by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). Several large European Notified Bodies also act as Canadian Registrars. Your new ISO 13485 certificate will be issued upon successful completion of the audit.

Step 4

For Class I devices, Apply for a Canadian Medical Device License (MDL) application for your device. Compared to a US 510(k) application, MDL applications are simpler for Class II devices and about the same for Class III devices. Class IV MDL applications are comparable to a US PMA application. 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, submit MDEL application, prepare mandatory procedures and pay Health Canada fees. For Class II devices, submit MDL application, IFU, Declaration of Conformity and ISO 13485 certificate. Pay Health Canada fees. For Class III and IV devices, submit MDL application plus Declaration of Conformity, ISO 13485 certificate, IFU and Premarket Review Document following the STED format, which may include clinical data. Clinical data collected outside Canada is generally accepted. Pay Health Canada fees.

Step 6

For Class IV devices, Health Canada will review your MDL application and Premarket Review Document.

Step 7

Approved applications will be posted on the Health Canada website.

Step 8

You are now 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.

Other Jurisdictions

The Emergo website also has charts that describe the regulatory process in other jurisdictions including the US, Europe, and Australia.




Lily Lo

Lily manages the Procurement by Co-Design challenges to ensure effective collaboration between healthcare providers and vendors. See more…