Canada| Regulatory Market Profile
Updated January 1, 2023
Canadian Medical Device Classifications
Medical Devices
The Canadian medical device classification system is based largely on the European Union's classification system (though not identical) and uses a series of 16 rules.
There are 4 medical device classifications:
Class I - Lowest risk classification.
Examples: wheelchairs, adhesive strips
Class III - Medium to high risk devices.
Examples: infusion pumps, tracheal stents
Class II - Low to medium risk devices.
Examples: disposable surgical instruments, daily wear contact lenses
Class IV - Highest risk devices.
Examples: pacemaker, heart valve
In Vitro Diagnostic Devices
The Canadian medical device classification system uses a series of 9 rules to classify IVD devices.
Devices are generally classified as follows, but there are exceptions to each classification rule:
Class I - IVD devices whose use has minimal public or individual health risks, such as in vitro diagnostic equipment and general diagnostic reagents.
Class III devices - IVD device whose use has either a moderate public health risk or a high individual risk.
Class II devices - IVD devices whose use has either a low risk to public health or a moderate risk to individuals.
Class IV - IVD devices whose use has a high public health risk. These include IVDs intended to ensure the safety of blood and tissue products used for transfusion or transplant, along with IVDs used to detect the presence of a transmissible agent that can be life-threatening and has the risk of propagating to the general population.
Medical Device Market Requirements in Canada
There are four major steps to bringing a medical device to market in Canada:
Classify your device.
Establish QMS procedures. Class II, III, IV must demonstrate compliance with ISO 13485:2016 through an MDSAP certificate by an approved auditing organization.
For Class I devices, obtain a Medical Device Establishment License (MDEL). For Class II, III, and IV devices, obtain a Medical Device License (MDL).
Pay applicable fees after initial application is accepted.
Canadian UDI Requirements
Health Canada has proposed a UDI framework based closely on the international UDI guidance from the IMDRF.
The current proposal involves requiring UDI labeling for all devices, with the exception of Class I low-risk devices. Health Canada intends to either develop a UDI database or modify the existing Medical Devices Active License Listing database (MDALL) to accommodate UDI data. It is expected that, like most countries, Canada will add a small number of additional UDI data attributes to be required.
Standards and Essential Requirements in Canada
Canada has published a list of recognized standards, some of which we list below. You should refer to the Health Canada's website for a full list of recognized standards and updated versions.
ISO 10993 (multiple parts) - Biological evaluation of medical devices
IEC 60601 (multiple parts) - Medical electrical equipment
ISO 14971:2019 - Application of risk management to medical devices
ISO 11135:2014/Amd 1:2018 - Sterilization of healthcare products
Canadian Medical Device Registration Fees
Current fees for new medical device applications, establishment licenses, and right to sell licenses are listed below. For a full and updated list, including fees for amendments, refer to the Health Canada website.
Application fees:
Category
Fee
(as of April 1, 2023)
Fee
(as of April 1, 2024)
Application for Class II license
$589
Application for Class III license
$12,987
$13,559
Application for Class III license for near-patient IVD
$27,666
$28,884
Application for Class IV license
$28,165
$29,405
Establishment license and right to sell fees:
Category
Fee
(as of April 1, 2023)
Fee
(as of April 1, 2024)
Medical Device Establishment License (MDEL)
$5,060
Annual fee for the right to sell a licensed Class II, III, or IV medical device
$421
$440
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