PreMarket Medical Devices in Canada

Applicants, may it be the manufacturer, importer, or distributor must obtain a license before their product is released to the Canadian market (PreMarket Medical Devices in Canada essential step). This is true for all types of products, may it be drugs, foods, cosmetics, and even medical devices. Products which fall under the “device” from the Foods and Drugs Act, will be classified based on the risks associated with their use. Let’s see below the process.

Classification Rules for Medical Devices

It is the applicants’ responsibility to determine the classification of the medical device according to PreMarket Medical Devices in Canada. There are actually four device classifications – Class I, Class II, Class III, and Class IV where Class I represents the lowest risk and Class IV represents the highest risk. If a medical device falls under multiple classes, then the class representing the higher risk will apply.

Safety and Effectiveness Requirements

The applicant has the duty to comply with all requirements of all of the Canadian Medical Device Regulations and to provide evidence of compliance.

PreMarket Medical Devices in Canada includes regulation related to medical devices’ safety and effectiveness. Generally, a medical device must be designed and manufactured to be safe and effective. The safety and effectiveness requirements are as follows:

The manufacturer must take measures to identify risks associated with the device and eliminated the risks if possible. If risks cannot be eliminated, it must be reduced, provide protection appropriate with the risks, provide information relative to the risks; and to minimize hazard from potential failures during the useful life of the device.
The medical device must perform and must be effective for the medical condition or its intended purpose, use.
The medical device must not have an adverse effect on the health or safety of the patient or user when the device is used for its purpose. The adverse effect is considered an acceptable risk if the effect is outweighed by the benefits to the patient.
The performance and characteristics of the medical device must not decline during the projected useful life of the device, such that the health and safety of the patient or user is affected
The performance and characteristics of the medical device must not be affected by storage conditions and transport taking into account the manufacturer’s transport and storage information
Every material used in the manufacture of the medical device must be compatible with every other material used and must not interact with other material it comes in contact with during use, hence must not pose risk to patient or user
The design, manufacture, and packaging of the medical device must minimize risk to the patient or user from foreseeable hazards such as flammability, radiation, presence of contaminants or residue, electrical or mechanical hazards, fluid leaks
Sterilization method of medical devices sold in sterile condition must be validated
Performance of software must be validated for medical devices involving software

Labeling Requirements

Medical devices without a compliant label must not be sold or imported. Pre-Market Medical Devices in Canada labeling requirements are as follows:

Device name
Manufacturer name and address
Device identifier including identifier of any medical device part of a system, kit, medical device group, or medical device family
Control number for Class III or Class IV
Indication of package contents appropriate to the device if contents are not readily obvious, such as size, net weight, length, or volume
The word “Sterile” for devices sold in sterile condition
Expiration date of the medical device
The purposes, uses, and medical conditions to which the medical device is intended for, including performance specifications
The directions for use, unless not required, for the device to be used safely and effectively
Storage conditions applicable to the medical device

All the required information must be expressed in a permanent, prominent, and legible manner in terms easily understood by the user.

Licensing Requirements

Medical devices which fall under Class I devices must apply for a Medical Device Establishment License (MDEL) and those under Class II, III, and IV must apply for Canadian Medical Device License (MDL).

Licensing of establishments ensures that Health Canada is aware of the identities of those manufacturing, importing, and selling medical devices. It also allows establishments to assure Health Canada that they have complied with all the regulatory requirements for PreMarket Medical Devices in Canada.

The applicant must then file for the necessary application and submit the necessary requirements:

Class I

Application for Medical Device Establishment License containing the name, class, identifier of the device; name and address of manufacturer; name and address of establishment if different from manufacturer
Compliant Label

Class II

Application for Medical Device License containing the name, class, identifier of the device; name and address of manufacturer; name and address of establishment if different from manufacturer
Description of medical conditions, purposes, and uses which the device is manufactured, sold, or represented
Declaration of Conformity
Quality management System Certificate
Compliant Label

Class III

Application for Medical Device License containing the name, class, identifier of the device; name and address of manufacturer; name and address of establishment if different from manufacturer
Description of the device and the materials used in the manufacture and packaging
Description of the device’s features that allow it to be used for the medical conditions, purposes, and uses for which it is manufactured, sold, or represented
List of countries other than Canada where the device has been sold, total number of units sold, and summary or reported problems/any recalls of the device in those countries
Declaration of Conformity
Quality management System Certificate
Compliant Label
Premarket Review Documents

Class IV

Application for Medical Device License containing the name, class, identifier of the device; name and address of manufacturer; name and address of establishment if different from manufacturer
Description of the device and the materials used in the manufacture and packaging
Description of the device’s features that allow it to be used for the medical conditions, purposes, and uses for which it is manufactured, sold, or represented
List of countries other than Canada where the device has been sold, total number of units sold, and summary or reported problems/any recalls of the device in those countries
Risk assessment that contains an analysis and evaluation of risks, and the risk reduction measures taken to conform with the requirements
Quality plan that sets out specific quality practices, sequence of activities, and resources related to the device
Manufacturing process of the medical device
Declaration of Conformity
Quality management System Certificate
Compliant Label
Premarket Review Documents