How Medical Devices are Classified in Canada
Regulatory Classification Basics for your Medical Device:
There are certain rules that apply to a medical device classification, and it varies between different regulatory agencies. The classifications are related to the perceived risk of the product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.
Why does Regulatory Classification even matter for my Medical Device?
Knowing how your medical device is classified matters so that we can determine what is required to be done before the medical device is sold in Canada. Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.
Medical Device Classification in Canada
The medical devices regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:
- Invasive Devices (Rules 1-3)
- Non-Invasive Devices (Rules 4-7)
- Active Devices (Rules 8-12)
- Special Rules (Rules 13-16)
For each of the broad categories, there are a set of rules that apply. Manufacturers should follow these rules to determine the risk classification of their medical devices. For example, you are interested in marketing a percutaneous catheter in Canada. After reviewing the Risk-Based Classification System for non-IVDDs, we would determine for you that the percutaneous catheter is an invasive device. To classify the device, we’d review all the options and conclude that Rule 1 applies for you. Further, based on the intent of use, the medical device is classified as a Class II medical device in Canada. There are similar risk-based classification systems for in vitro diagnostic medical devices and Software as a Medical Device (SaMD).
Medical Device Licence (MDL) in Canada
Overall, there are four levels of medical device classifications based on the level of risk (low to high) in Canada: Class I, Class II, Class III, and Class IV. Before going to market in Canada, a manufacturer must first apply for a medical device license (MDL).
Class, I medical devices do not require a license. There are different applications for Class II, Class III, and Class IV medical devices, and the application complexity increases as the risk classification increases.
There is a keyword index document available to assist manufacturers in verifying the class of medical devices is an alphabetical listing of all the short descriptors for devices that are entered into the medical devices system. This document contains synonyms and industry words that are used to describe these devices, along with their respective classifications.
Manufacturers of Class II, III, and Class IV medical devices can receive their MDL license by submitting a premarket application. This can be in either the ToC or Health Canada formats, for entering the Canadian market. Additionally, the manufacturers should obtain an ISO 13485 certification with Medical Device Single Audit Program (MDSAP).
Medical Device Active Licence Listing (MDALL)
Once Health Canada approves the Medical Device Licence, the device information is maintained in the Medical Devices Bureau database for Class II, Class III, and Class IV devices. Class I medical devices do not require an MDL as they are monitored by the Health Products and Food Branch Inspectorate through establishment licensing.
The MDALL online query allows you to search for medical devices with an active MDL. A search can be done by company name, company ID, license name, license number, device name, and device identifier. A device identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalog number of the device is often selected for this purpose.
Medical Device Licence Renewal in Canada
The medical device license renewal process in Canada has two purposes. The first is to confirm whether the medical device will continue to be sold in Canada and whether the medical device license will remain active. The second is to collect information that must be assessed prior to invoicing for market authorization.
Manufacturers of medical devices that are licensed for sale in Canada are required to inform Health Canada each year before November 1 that the information submitted with their license application and any subsequent amendments have not changed. This is referred to as the medical device license renewal process. Manufacturers of licensed Class II, III, and IV medical devices are charged an annual fee, payable at the time of license renewal, for the right to sell their devices in Canada. The fee is charged annually for the twelve-month period beginning on November 1 of each year. Manufacturers must notify Health Canada if there is a change regarding the regulatory correspondent or contact information previously submitted. Failure to do so may result in the cancellation of your medical license.
How Quality Smart Solutions can help
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: https://qualitysmartsolutions.com/contact/