Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification of your medical device is critical to ensuring it’s compliant with the rules.
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What Is Medical Device Classification by Health Canada?
Medical device classification by Health Canada is based on the risk of harm posed by a device and the control required for its safe use. Devices are categorized into four classes, from Class I (lowest risk) to Class IV (highest risk). In addition, some medical devices may require licensing before marketing or importation to ensure that acceptable safety and performance standards are maintained.
What are the Labelling Requirements for Medical Devices?
Labeling medical devices is crucial for marketing and selling a device in Canada. Labels must include clear instructions for use, statements on risks and limitations, the number of Health Canada Establishment Licenses (EL), where appropriate, the manufacturer’s name and place of business, and other pertinent information such as expiry dates. It is also essential to identify the contents of each package accurately to ensure that they do not pose any safety threats or lead to device misuse.
Protocols and guidelines regarding classification tests
Health Canada has issued a set of protocols and guidelines to determine the classification of medical devices according to their intended use. These standards refer to physical, chemical, electrical, and biological tests to accurately assess the characteristics and performance of the device. The results of these tests, along with an evaluation of the device’s design, labeling, and instructions for use, are used to distinguish between different classes of devices. The classifications are relatively risk-based (e.g., Class I versus Class II) and are essential for regulating manufacturers’ marketing and distribution of medical devices in Canada.
What are the regulatory classification basics for your medical device?
Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market. Specific rules apply to a medical device’s classification and vary between regulatory agencies. The categories are related to the perceived risk of the product type.
Why does regulatory classification even matter for my medical device?
Knowing how your medical device is classified matters so that we can determine what must be done before the medical device is sold in Canada. Furthermore, the classification determines the product’s design and what controls are required. Lastly, timelines around bringing your device to market and costs can be estimated once the device class is determined.
Medical Device Classification in Canada (MDALL, MDL, MDEL)
The Medical device regulations in Canada are established by the Government of Canada and regulated by Health Canada. Health Canada defines a risk-based classification system 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, a set of rules 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 that the percutaneous catheter is invasive. To classify the device, we’d review all the options and conclude that Rule 1 applies to you. Further, based on the intent of use, the medical device is classified as a Class II medical device in Canada. Similar risk-based classification systems exist for in vitro diagnostic medical devices and Software as a Medical Device (SaMD).
What are the different types of medical devices?
Medical devices are classified into four different categories, depending on the degree of risk associated with them. Class I devices have the lowest risk, while Class IV devices have the highest chance. The four classes of medical devices are I, II, III, and IV. The classification criteria are based on the type of device, its intended use, and the potential level of risk the device poses.
What are the medical device classification requirements?
The FDA has specific requirements for classifying medical devices, which can be broken down into three categories: intended use, technical characteristics, and performance criteria. These factors must be considered before a device can be classified accordingly. For instance, the intended use of a machine is an essential factor as it determines how it will be used and in what situations. In contrast, its technical characteristics are used to assess how technologically advanced the device is. Lastly, performance criteria look at the potential risks associated with a device and evaluate its effectiveness in addressing them.
How do each medical device’s risk and complexity determine classifications?
The risk associated with a medical device depends on its complexity, performance, and intended use. Generally speaking, the more complex the device and its performance requirements, the greater the associated risks. As a result, devices are most often classified according to their risk level, from Class I (low risk) to Class III (high risk). This classification system helps healthcare practitioners determine appropriate controls for each device based on its risks and potential impact on the health or safety of patients.
When is medical device reclassification necessary?
Reclassification may be necessary in certain circumstances. For example, if the design of a device has changed significantly since its initial approval or if there is a new indication that was not previously reviewed, it may be appropriate to reassess and reclassify the device. Additionally, medical devices may need to be tested or retested periodically based on their reclassified risk level to ensure they perform as expected.
How can you use logo design to meet Regulatory compliance?
Logo design is essential in meeting medical device regulations, as logos must be easily read and visible on product labels. It’sIt’s vital to ensure the logo is aligned with existing regulatory guidelines and communicates essential information to protect patients from potential risks. The logo should clearly explain the type of device, its intended use, and any necessary safety precautions. Additionally, the logo should not contain any misleading information or images that could create confusion when selecting or using a medical device.
Medical Device License (MDL) in Canada
Overall, there are four 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 apply for a medical device license (MDL). Class I medical devices do not require a permit. There are different applications for Class II, Class III, and Class IV medical devices, and the application complexity increases as the risk classification increases.
A keyword index document is available to assist manufacturers in verifying the class of medical devices. It is an alphabetical listing of all the short descriptors for devices entered into the medical device system. This document contains synonyms and industry words used to describe these devices and their respective classifications.
Class II, III, and IV medical device manufacturers can receive their MDL license by submitting a pre-market application. This can be in the ToC or Health Canada formats for entering the Canadian market. Additionally, the manufacturers should obtain ISO 13485 certification through the Medical Device Single Audit Program (MDSAP).
Medical Device Active License Listing (MDALL)
Once Health Canada approves the medical device license, information is maintained in the Medical Devices Bureau database for Class II, III, and 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 License 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 before invoicing for market authorization.
Manufacturers of medical devices licensed for sale in Canada must inform Health Canada each year before November 1 that the information submitted with their license application and any subsequent amendments have stayed the same. This is referred to as the “medical device license renewal process.”
Licensed Class II, III, and IV medical device manufacturers are charged an annual fee, payable at the time of license renewal, for the right to sell their devices in Canada. The price is charged annually for the twelve months 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. Please do so to avoid the cancellation of your medical license.
What are the benefits of using MDALL in your operations?
Automated workflow: MDALL boosts your operational efficiency and productivity by allowing you to automate everyday tasks such as sourcing and procuring supplies, sending invoices, and tracking inventory. Automating your business processes with MDALL ensures accuracy and reduces errors associated with manual data entry. With automated workflows enabled, you can quickly complete projects while saving valuable time and money.
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Streamlined and cost-effective operations: MDALL can help you cut costs by streamlining your processes with automated workflows and integrated third-party apps. This solution helps increase the visibility of key performance indicators to identify inefficiencies and target areas for improvement, reducing errors and eliminating unnecessary processes. In addition, the reduced manual labor allows you to save on training costs for new hires and ongoing labor printing costs.
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What is the medical device listing process?
The medical device listing process is a legal requirement for any company offering medical devices for sale. The process involves:
- Registering with the FDA as a manufacturer.
- Providing essential information about your medical device.
- Testing it to ensure safety and efficacy.
This process helps to protect patients from faulty or dangerous products while allowing companies to prove that they comply with all applicable regulations.
How do I prepare items for my medical device listing?
Preparing items for your medical device listing is a crucial step in the process. To get started, you must compile technical information about each device and product, such as performance data and applicable regulations. You’ll also need supporting documentation for your listing, such as test reports and risk analyses, which an independent third-party laboratory must approve before submission. Once this information is gathered, your medical device company can submit the listing to the FDA, officially notifying them that it is on the market.
Which medical devices require a medical device listing?
Most medical devices must be listed with the FDA before they are allowed on the market. The list of medical devices that need to be listed includes but is not limited to implants, dental instruments, diagnostic equipment, prosthetics, mobility aids, surgical tools, and specialized medical equipment. While particular class 1 devices do not require a listing, any device with a higher risk (i.e., class 2 or above) should be listed for legal compliance.
What are the requirements for recertified or refurbished medical devices?
Recertified or refurbished medical device manufacturers must adhere to specific requirements when re-listing their products with the FDA. In general, all the same, information that is provided for a new product listing (such as the manufacturer name, device description, and catalog number) is necessary. Additionally, all pre-market reviews, clinical evaluations, and safety reporting documents should be provided as part of the re-certification process.
What type of information is required for a medical device listing?
Certain information is required when submitting a medical device listing to the FDA. This includes the manufacturer’s name and address, device description, type of device, date of manufacture and expiration date (if applicable), catalog number, purpose and use statement, suggested age and weight requirements for use, labeling information indicated on the packaging, or instructions for how the device should be used safely. Any additional information related to safety tests and quality control performance evaluations should also be included when submitting a listing for a medical device.
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 MDALL or MDEL licensing! Please find our contact information here:
