Regulations
Last Updated: 29 July 2026
In Canada, medical devices are regulated and controlled by Health Canada medical device registration of the Health Products and Food Branch, and Canada medical device regulation (SOR/98-282) is responsible for ensuring their safety, quality, and efficacy before they are placed on the Canadian market for sale and use.
Understand Health Canada Medical Device Classification
Under Canada's medical device regulatory system, Health Canada Medical Device Classifications are classified according to the risk class system. The higher the risk class of medical devices is, the more relevant documentation is needed to support registration and licensing applications in Canada. See the table below Canada medical device risk class and licence.
Quality Management And MDSAP
Before submitting the application for device in class II, III and IV you need to have a Quality Management System
ISO 13485 Compliance: is mandatory for a manufacturing facility.
MDSAP Requirement: Health Canada medical device registration requires certification according to the Medical Device Single Audit Program which allows for harmonized audit recognition by the regulatory authorities of the USA, Australia, and Brazil. MDSAP certificate is mandatory for Medical Device License for Class II, III, and IV MDL applications or MDL application in Canada, without it, your application will be declined at the very beginning.
The digital submission portals (REP & CESG)
As of January 2026, Health Canada medical device regulation discontinued the practice of email submissions and transitioned to digital submission portals, and the new process includes the following:
The Regulatory Enrolment Process (REP)
Under the new changes, manufacturers are now required to use templates to register companies and prepare documents in XML format, the latter of which allows for faster processing and fewer errors in applications.
The Common Electronic Submissions Gateway (CESG)
Once the REP files are ready, they need to be submitted through the CESG, which is a rapid electronic filing gateway. This same system is also used by the US FDA, and manufacturers must set up a CESG account to submit regulatory dossiers to Health Canada Medical Device .
Required Documentation for Submission
The Technical Dossier is the information you are required to provide as a part of your application. In 2026, the Technical Dossier follows the IMDRF Table of Contents format.
For Class I Applications:
Class I devices do not require an MDL, rather they require a Health Canada Medical Device Establishment Licence (MDEL). Since the MDEL is an establishment licence (and not a technical device evaluation), it is unusual for a class I application to include a technical dossier in IMDRF ToC format, as it is not typically submitted to Health Canada.
For Class II Applications:
Applications for class II devices are “summary” based. The following are typically required for a class II application:
An MDL application form (through REP)
A valid MDSAP certificate
French and English versions of device labelling and Instructions for Use (IFU)
Summary of studies supporting device safety and effectiveness
For Class III & IV Applications:
Class III and IV applications are “full” applications and will therefore require a complete technical specifications dossier that includes:
Clinical Evidence: This refers to the clinical studies performed or reported on the device in question including clinical trials performed on humans to demonstrate safety and effectiveness;
Risk Management: A complete risk management assessment including rationale for risk reduction or elimination;
Manufacturing Process: A description of process used to assemble, sterilize and package the device;
Software Validation: Devices utilizing software as a medical device (SaMD) or standalone SaMDs require a complete software validation data package for regulatory submission.
Health Canada Medical Device Regulation updates its fee schedule each year, based on the cost of regulatory reviews. Application fees are mandatory and due upon submission of your application.
Health Canada Medical Device Registration Time
Health Canada medical device registration time is divided into several categories based on the class of a device. The timeline is defined in terms of days from the beginning of the review process, which starts when your application has been cleared during the initial screening.
Class II - 15 days
Class III - 75 days
Class IV - 90 days
MDEL - 120 days
If Health Canada issues a Clarification Request to you, they will pause the clock until they receive your response to their query, so it’s critical to provide the necessary response as soon as possible.
Post market Requirements
Obtaining the license is the first step. To keep your product on the market you have to make sure that you comply with specific requirements :
Mandatory Problem Reporting: Report any incidents resulting in serious injury or death to the agency within 10-30 days after the incident occurred.
Renewal of Licence: There is a need to renew the annual license after one year with the payment of the appropriate fees to the rightful authority. It also involves the verification of the information provided for licensing.
Complaint Handling: This pertains to the maintenance of a written procedure concerning the handling of complaints by the manufacturer.
Recall Procedures: This is the procedure that requires a firm recall of a device from the market when it is found to be defective. The procedure entails a comprehensive plan of the removal of the devices from the market at all levels and should always be available for easy access. This recall procedure is considered an essential part of the product.
How Can Morulaa Help
Morulaa, with consultants spread across Canada, has helped in the navigation of medical devices in the Canadian market. We offer services such as identifying your device’s classification and completion and filing of Canadian medical device licence (MDL) or medical device establishment licence (MDEL) applications. Morulaa can also be your contact person in dealing with the official regulatory correspondent with Health Canada for your MDL or MDEL Contact us for Health Canada Medical Device Registration.
Frequently Asked Questions (FAQs)
What is the first step for Health Canada medical device registration?
The first step for Health Canada Medical device registration is to identify your products’ risk category (Class I to IV) according to the 16 classification rules established by Health Canada. Based on your device’s class, you need to determine the type of registration needed for legal sales in Canada. Meanwhile, Class I medical devices apply for a Medical Device Establishment Licence (MDEL). By contrast, Class II medical devices, Class III medical devices, and Class IV medical devices need a Quality Management System audit (MDSAP) followed by a Medical Device License (MDL) application.
Is the Regulatory Enrolment Process (REP) still optional for submissions?
No, Regulatory Enrolment Process (REP) is no longer optional for Health Canada submissions. The REP, a set of processes for electronic submission to Health Canada Medical Device Regulation, has officially turned into mandatory regulation. As of now, all medical device submissions to Health Canada, including Class II, Class III, and Class IV Medical Device License (MDL) applications, amendments, and other regulatory transactions, need to follow the new eCTD XML standards and be submitted through the Common Electronic Submissions Gateway (CESG).
What is the difference between MDL and MDEL?
MDL (Medical Device License) is a product specific authorization provided by Health Canada to manufacturers granting the right to market, sell, and distribute medical devices on Canadian territory. MDEL (Medical Device Establishment Licence), in turn, is a type of business licence needed for importers, distributors, and Class I medical device manufacturers to legally place devices on the Canadian market.
How do I verify that a medical device is authorized for sale in Canada?
To check if a medical device is authorized for sale in Canada, you need to search the Medical Devices Active Licence Listing MDALL Canada for Class II, Class III, and Class IV medical devices and the Medical Devices Establishment Licence Listing for Class I medical devices. This official database of Health Canada contains an up to date list of authorized devices and medical device establishments. If you do not find a certain device or distributor on these lists, this means that the company is not authorized to legally sell medical devices in Canada.
What is the fee for Health Canada authorization?
The amount that must be paid for approval through Health Canada depends on the category of your medical device (I through IV) and the nature of your application, be it a new one or a modification of the existing one. While Health Canada does not have per product registration fees for medical devices, it is necessary to get a Medical Device Establishment Licence (MDEL), costing about $5,400 CAD yearly, for Class I devices or individual Medical Device Licences (MDL) for Class II, III and IV devices with the review fees varying from a few hundred dollars for low risk devices to more than $30,000 CAD for higher risk or complex diagnostics. These mandatory fees are established by the Government of Canada and must be paid in Canadian currency.
Why should I opt for Health Canada regulatory Consultant experts services?
Health Canada regulatory consultants eliminate the risks associated with complicated XML structure development, inappropriate IMDRF Table of Contents organization, and bilingual (English and French) labelling requirements. The expertise of an experienced Health Canada regulatory consultant covers every aspect of the regulatory affairs process in Canada. From setting up your accounts and portals for electronic submissions to preparing your technical files for review and monitoring submissions to the authorities, all tasks are done to ensure timely registration for your medical devices in Canada.