Approval and Registration Process of Medical Devices in Canada

A medical device is any instrument or component used to treat, diagnose, or prevent a disease or abnormal physical condition. Veterinary or animal-related devices are not included under the category of medical devices. The medical device market in Canada is well-established and highly diversified, with a preponderance of small and medium-sized businesses. The market currently has a worth of about USD $6.5 billion, with continued growth until 2026 at a 2.1% annual growth rate.

Less well understood, however, is how Canada oversees medical devices and how this positions them within the global context. Compared to the U.S. framework regulating medical devices, the current Canadian regulatory system is rather short. While the origins of food and drug regulation in both countries can be traced to the early 20th century, Canada's current medical device regulatory paradigm has taken shape from converging international developments and rapid technological progress, driven by a proactive regulatory policy supported by global consensus.

This paper traces the history of the Canadian regulatory system for medical devices to the present. It aims to provide insight into the development of this framework, Canada's participation in harmonization, the subtle regulatory distinctions within Canadian legislation, and its current policies toward emerging technologies.

Classification of Medical Devices

Medical devices are classified according to Health Canada’s risk-based system. 

There are four device classifications — 

Class I, 

Class II, 

Class III 

Class IV

using a set of 16 rules found in Canadian Medical Devices Regulations. 

In vitro diagnostic (IVD) devices are also classified as Class I through IV using a set of nine rules. Device classification dictates the license type required for your product and quality management system (QMS) requirements. Class II, III and IV devices require a product-specific Canadian Medical Device License (MDL), and manufacturers must hold ISO 13485 certification under the Medical Device Single Audit Program (MDSAP). 

A Medical Device Establishment License (MDEL), held by the manufacturer or distributor, is required for Class I products. Class I devices are approximately 40% of approved devices Every higher level of device class, like in the US, entails more regulatory scrutiny for your gadget. The criteria used to classify devices are a little varied, and they include things like potential contact with a patient's nervous or cardiovascular system, dependence on an energy source, and invasiveness.

In Canada, class I devices can be sold without a license. Class II devices require a license application. To gain approval for a CLA class III device, organizations must submit a valid ISO 13485 certificate. Applicants for Class IV devices are required to apply, an ISO 13485 certificate, and other comprehensive safety data to Health Canada. Devices classified as Class IV are assessed in 75 days.

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Classification of Medical Device

Canadian Classification	Risk Level	Examples
Class I	Lowest	Reusable Surgical Scalpel, bandages, culture media
Class II	Low	Contact lenses, Epidural Catheters, Pregnancy Tests Kit, Surgical Gloves
Class III	Moderate	Orthopedics implants, Glucose Monitors, Dental Implants, Hemodialysis Systems, Diagnostic Ultrasound Systems
Class IV	High	HIV Tests Kits, Pacemakers, Angioplasty Catheters

Application Fees

In Canada, Class I medical devices are exempt from device license applications and are not required to pay any fee. The fees for Class II, III, and IV devices could be significantly different. According to Health Canada, the fees as of April 1, 2023, are as follows:

1. Class II License Application $589 CAD
2. Class III License Application $12,987 CAD
3. Class IV License Application $28,165 CAD These fees can vary slightly. For example, the application fee for a near-patient diagnostic in vitro Class III device is significantly higher at $27,666 CAD.

Medical Device Registration in Canada

Firstly, the Manufacturers willing to sell their devices in Canada must obtain MDSAP certification. 

To market the devices in Canada, manufacturers must obtain a license. 

There are two types of licenses issued by Health Canada: 

1. MDEL (Medical Device Establishment License) – Class I Medical Devices 
2. MDL (Medical Device License) – Class II, Class III and Class IV Medical Device 

Certification and Timeline

• The Medical Device Manufacturers willing to place their medical devices in the Canadian market must have MDL as well as ISO 13485: 2016. 
• The time needed for MDEL – 120 Days 
• Time needed for MDL – 15 Days (Class II Medical Device), Class III – 75 days; Class IV – 90 days.
• The MDL license is intended for the device's approval. In contrast, the manufacturer, distributor, and importer company receive MDEL.
• The medical device license is valid for one year.

Step by Step process to get registration of your medical device in Canada

If you are looking for a manufacturing partner who can help you enter the Canadian markets, then follow these steps:

• Step 1: Determine the class of your Medical Device. A device may fall into Class I, Class II, Class III, or Class IV
• Step 2: All the devices except Class I devices must comply with all guidelines of ISO:13485 certification
• Step 3: For all the devices under ISO: 13485 re-audits are done by an approved Auditing organization. New MDSAP will be issued on successful completion of the audit
• Step 4: Class I Medical Devices must acquire MDEL certification. Devices classified as Class II, III, and IV require MDL certification.
• Step 5: Submit the fees and documents as per your device requirement. For Class I Medical Device you’ll be required to prepare mandatory procedures documents and pay the Health Canada fees. For Class II devices, submit an MDL application, Fees, labeling, Conformity declaration, and other major required documents
• Step 6: Health Canada reviews the application
• Step 7: Once the device is approved the information will be available on the Health Canada website. You will also receive a letter from MDEL through mail.

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