Medical Device Regulations (MDL, MDEL & SaMD)

Medical Device Registration in Canada & Classification
Health Canada Medical Device Regulations (MDL, MDEL & SaMD)

Talk to an expert now to know about Canada medical device classification. Get an In Vitro Diagnostic (IVD) Medical Device License (MDL) from Health Canada and we can also assist you in getting 510(k) submissions for IVD devices in the US. Learn more about Medical Devices Qualification in Canada and get your device regsitered quickly with Arora Consultancy.

Medical device compliance's most dependable consulting partner! To ensure that your devices comply with Health Canada's medical device rules, seek assistance from former Health Canada specialists. Medical devices are governed by Health Canada to guarantee their quality, efficacy, and safety. Learn about additional Medical Device requirements for Registration and selling or commercially importing a medical device in Canada as well as how Medical Device Regulations are created and updated.

Health Canada Medical Device Registration Process

In order to sell a medical device legally in Canada, you need to have Medical Device Registration in Canada according to Medical Device Regulations Canada.

Medical Device Regulations

There are several classifications of medical devices, and the majority of classes need license. The Therapeutic Products Directorate (TPD), more particularly the Medical Devices Bureau, oversees medical devices in Canada to guarantee their efficacy, safety, and quality.
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Health Canada Medical Device Classification

Health Canada's risk-based practice determines how medical devices are classified in this country. There are four different device classifications: Classes I, II, III, and IV. The classification of medical devices determines the kind of license your medical device needs.
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Medical Device Registration in Canada

An illustration of a medical device class I is a thermometer. Medical device licenses are not necessary for Class I medical devices. However, in order to be sold in Canada, medical devices of Classes II, III, and IV must first get a license. A product-specific Canadian Medical Device License is required for Class II, III, and IV devices (MDL).
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Different Medical Device Classes Review Time
  • Class II
    Class II Medical Device

    A 15 calendar day review time objective is set for class II medical equipment.

  • Class III
    Class III Medical Device

    A 75 calendar day review time objective is set for class II medical equipment.

  • Class IV
    Class IV Medical Device

    A 90 calendar day review time objective is set for class II medical equipment.

Canada Medical Device License Regulations

One of the greatest regulatory frameworks in the world ensures the effectiveness, security, and safety of medical devices sold in Canada. The Medical Device Regulations Canada make ensuring that businesses participating in the production, labelling, packing, and importation of medical equipment for sale do so in a legal and ethical manner.

Medical Device Classification Canada

Understanding how medical devices are classified is essential to understanding how these devices are controlled and what qualifications might be needed for their use. In Canada, there are four main classifications for medical devices in Canada, ranging from Class I to Class IV. The GMDN system classifies devices according to their complexity and assigns them to the correct group. Class II, III, and IV devices usually have more severe health effects or are inherently intrusive, necessitating more regulatory oversight and testing prior to market authorisation.
Global Medical Device Nomenclature (GMDN)
The Global Medical Device Nomenclature (GMDN) must be used to classify all medical devices used in Canada . This widely accepted method creates and uses uniform product descriptions to guarantee regulatory suitability and precise registration processes. Adopting the GMDN enables Canadian institutions to advance patient safety and take advantage of international trends when creating efficient medical device policies.
Notarial Requirements for Medical Device Approval
Manufacturers must submit their products to Health Canada for categorization and receive the required manufacturing license in order to have a medical device approved in Canada. As part of this procedure, manufacturers could also be required to have a third party notary certify that the device was made in accordance with all Health Canada-established requirements. The verification of items for radiation safety and conformity with Canadian regulations, including any safety labels or warnings, are additional notarial obligations.
Application Fee for Class II, III, and IV, Health Canada Medical Device License
For Class II, III, and IV medical devices, Health Canada charges a licensing application evaluation fee. Depending on the class, whether the device uses human or animal tissue, or if it is intended for in-vitro diagnostic application, the fees will change (Class IV). Health Canada charges start at $522 and rise yearly as of April 1, 2022. Your medical device will be placed on Health Canada's public website as soon as the license is granted.

Medical Device Establishment License (MDEL)

Production facilities must comply with the requirements of the Quality Management Program (QMP) in order to manufacture medical devices in Canada. The QMP should include product-specific requirements, such as labelling, packing, and handling processes, and it should encompass all phases of device manufacture. Additionally, producers must show that they have a procedure in place to examine any possible product instability and, if necessary, deal with consumer concerns.
How We Help with Health Canada Medical Device Registration in Canada

We have expertise working with thousands of medical device startups in Canada. We'll support you.

We have expertise working with thousands of medical device startups in Canada. We'll support you.

  • Verify your classification of Medical Device in Canada.
  • On your behalf, complete and submit MDL or MDEL applications.
  • serve as your regulatory representative when registering your Medical device with Health Canada.
  • To comply with Medical Device regulations Canada, develop, implement, and upgrade your quality management system.
  • Make sure to pay Health Canada's yearly licensing fee on time.
  • Offer on-site audits to verify adherence to Health Canada's regulations for medical devices.

An infographic displaying the process of obtaining a medical device license in Canada.

Medical Device Compliance Solutions in Canada

By offering solutions for licensing, regulatory review, and label compliance, Arora 297 Consultancy assists clients in adhering to Canadian medical device requirements. For businesses looking to create a reputable medical device manufacturing plant, we provide tailored solutions.

MDL Class Determination and Registration

Our Officers of compliance make certain that your medical devices are compliant with the Medical Devices Regulations Canada and that a license is granted so that your product get posted on Health Canada's public website after Medical Device Registration Canada.
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Medical Device Establishment License (MDEL) Registration

Get help in distributing, importing and manufacturing medical Devices in Canada from our professional team. We assist you in achieving ISO 13485 or 13488 requirements so you may obtain a medical device establishment license (MDEL).
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In Vitro Diagnostic Devices (IVD) Registration

By assisting with registration and acquiring a Medical Device License (MDL) from Health Canada, our specialists can help you sell In Vitro Diagnostic (IVD) equipment in Canada.
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SaMD Classification and Registration

With the assistance of our professionals, register the software for your medical device with Health Canada. Our experts can assist you in establishing the risk assessment, inclusion, and exclusion criteria for your device.
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QIS MDEL Import Agent

We make sure that every medical device imported into Canada complies with all applicable laws or medical device regulation canada.
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MDEL Renewal Solutions

Verify the accuracy of all supporting documentation and whether your operations have changed since the last renewal. Verify and evaluate all the facts to prevent rejection and sucessully process or MDeL
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Labeling, Packaging, and Claims Requirements Across Medical Device Classes
Labeling of medical devices and packaging of medical devices specifications vary between classes. For instance, Class I has the fewest criteria, calling only for the generic name of the item. Class III and Class IV, on the other hand, demand comprehensive product data, such as brand names, batch numbers, expiration dates, and more. Companies should be aware that some items require permission before they may be sold in Canada as therapeutic or diagnostic devices. This rule is applicable to all Class II, Class III, and the majority of Class IV medical devices.
What are the Health Canada Medical Device Regulations, and who is required to abide by them?
The manufacturing, sale, importation, and use of medical devices in Canada are all subject to a system of rules, legislation, and regulations created by Health Canada. They are designed to ensure that every medical equipment distributed or sold in Canada complies with the country's minimal requirements for quality, safety, and efficacy. Understanding these rules is crucial if you want to sell or distribute medical equipment while still abiding by the law. The Health Canada Medical Device Regulations must be followed by all parties working with medical devices. This covers businesses that have been granted permits by Health Canada, such as producers, labs, importers, and distributors.
How Do You Register Medical Device in Canada That Comply With Medical Device Regulations Canada ?

Companies must submit an application for registration of medical device that contains basic information about their company and device, as well as any necessary supporting documentation, in order to register a medical device with Health Canada in compliance with the relevant Medical Device Regulations Canada. Depending on the risk class given to the medical device, all registration criteria must be fulfilled, which can include further assessments or testing. Before their items may be registered, businesses must also give an accurate description of their devices and pertinent studies demonstrating conformity with current legislation.

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Frequently Asked Questions - Medical Device Regulations (FAQ's) !
How do I determine the classification of my medical device?
Image of Faq on HACCP process

Health Canada has established a classification system based on the risk associated with the medical device. The classification depends on factors such as the intended use, duration of contact with the body, and potential harm to the patient.

How can a regulatory consultancy firm help with Medical Device regulation?
Image of Faq on HACCP purpose

Regulatory consultancy firms, such as Arora 297 Consultancy, specialize in navigating the complex landscape of Medical Device regulation. They provide guidance on regulatory requirements, assist with licensing and registration processes, and ensure compliance with Health Canada's regulations and guidelines.

What is the process for obtaining a Medical Device License in Canada?
Image of Faq on HACCP steps

The process for obtaining a Medical Device License (MDL) in Canada involves submitting an application to Health Canada, providing detailed information about the device, its intended use, and supporting documentation such as clinical data, safety testing results, and quality management system certification.

What is the Medical Device Establishment License (MDEL)?
Image of Faq on HACCP plan

The Medical Device Establishment License (MDEL) is a license issued by Health Canada that allows a company or organization to import, distribute, or sell medical devices in Canada.

What is a Medical Device according to Health Canada?
Image of Faq on HACCP process explanation

Health Canada defines a Medical Device as any instrument, apparatus, machine, or other similar article that is used to diagnose, treat, or prevent a disease or a medical condition.