Canada: Marketing a Class I Device (Establishment Licenses, Labeling and Basic PMS)

Hello everybody and welcome back to MedTech Compliance Chronicles! After examining Canadian classification rules and detailing the universally applicable safety and effectiveness requirements, it is time to begin looking at the specific obligations that apply to each classification tier. In this post, we will focus on Class I medical devices, which represent the lowest risk category in Canada’s four-tier classification system. 

While these devices face fewer regulatory hurdles compared to Class II, III, and IV devices, they are still subject to important requirements under the Medical Devices Regulations (CMDR). Class I devices are regulated primarily through establishment licensing, post-market surveillance, and compliance with labeling requirements, rather than through pre-market device licensing. However, understanding these obligations in detail is critical for manufacturers, importers, and distributors aiming to remain compliant and ensure safe use of their products. In this post, we will outline the specific responsibilities of Class I device manufacturers. It should be noted that all of the requirements discussed in this post are also requirements of class II, III, and IV devices, but those devices have additional requirements to be discussed in future posts.

Pre-Market Requirements

Understanding the premarket requirements for Class I medical devices in Canada is essential for planning market entry. Class I medical devices are unique within the Canadian regulatory framework because they do not require a formal medical device license (MDL) from Health Canada prior to being sold. However, this exemption from the MDL process does not mean that Class I devices are free from premarket obligations. Before introducing a Class I device to the Canadian market, manufacturers, importers, and distributors must comply with a set of foundational regulatory requirements. 

Although Class I devices do not require a Medical Device License (MDL) for the device itself, the entity responsible for manufacturing, importing, or distributing the device must hold a MDEL. Any company that manufactures, imports, or distributes a Class I medical device in Canada must hold an MDEL, unless they choose to partner with an importer or distributor who already possesses this license. The MDEL application requires general information about the establishment, including the nature of its activities and the types of devices involved. While extensive documentation is not submitted with the application, the minister of Health Canada may ask at any time for evidence supporting the claims in the application. Therefore, establishments should maintain comprehensive records of all supporting evidence. The MDEL serves as Health Canada's mechanism for ensuring that all entities involved in the manufacture, import, or distribution of medical devices within Canada meet minimum standards for quality and safety. A final note on MDEL’s is that they must be renewed annually, prior to April 1st of each year with an attestation that these systems remain in place and effective. Any changes in ownership, name, or address must be reported promptly to Health Canada.

Beyond obtaining an MDEL, manufacturers are also expected to implement and maintain a quality management system (QMS), though third party certification of this QMS is not necessary for class I devices. The basic elements of the QMS in place must at least demonstrate that the device meets the general safety and performance requirements, as well as contain procedures for complaint handling, recalls and reporting obligations that meet Canadian regulatory requirements for those procedures (all to be discussed in future posts). 

The final aspect of premarket readiness for a Class I device are the labeling requirements, detailed in Section 21 of the CMDR. This includes providing bilingual (English and French) labeling that accurately reflects the device’s identity, intended use, manufacturer or importer information, and any warnings or precautions necessary for safe use. As part of the labeling, you must also provide descriptions of the medical conditions for which the device is to be used to treat / alleviate / diagnose and clear instructions for use targeted to the intended users. A quick note on what “targeted to the intended user” means, two different devices may be intended to treat the exact same condition, but one is intended to be used by a lay person while the other is intended to be used by a physician. The device intended for a lay user may use less technical language, and break the tasks up into smaller steps to avoid confusing the user, while the device intended for use by a physician may just provide general instructions, relying more on the physician's professional training and judgement to ensure safe and effective use.

Post-Market Requirements

Once a Class I medical device enters the Canadian market, manufacturers, importers, and distributors must comply with a range of post-market obligations designed to ensure ongoing safety and regulatory compliance. These obligations ensure that safety information continues to be monitored throughout the device's commercial lifecycle, enabling prompt identification and resolution of potential issues that may emerge after market introduction.

At the core of post-market oversight is the requirement to maintain detailed distribution records. These records must allow the company to identify where each device batch or lot has been distributed, making it possible to trace and recall affected products quickly in the event of a safety issue. The regulations require that distribution records be retained for the longer of either the expected lifetime of the device or two years from the date the device was shipped.

Closely tied to distribution tracking is maintaining a functional recall procedure. All companies that hold an MDEL must have written procedures in place for initiating, managing, and documenting a product recall. This includes the internal evaluation of whether a recall is necessary, notification of affected parties, coordination with Health Canada, and thorough documentation of the recall process. In the event that a recall is conducted, Health Canada must be notified promptly, and reports must be submitted. Following suit, sellers of class I devices in Canada must comply with all reporting obligations of adverse events, and, since manufacturers are often notified of such events via complaints, must also maintain a documented complaint handling procedure.

Finally, it is important to note that Health Canada reserves the right to inspect any holder of an MDEL to ensure that all of these requirements are continually being met. Even though companies who only sell class I devices are less likely to be selected for inspection, if an inspection occurs a failure to maintain adequate procedures or documentation may result in compliance action, including the suspension or cancellation of the MDEL. If an MDEL is suspended or cancelled, the holder of the MDEL will have to submit evidence of correction of the issues that caused the suspension prior to it being reissued.

Conclusion

The journey of bringing a medical device to market in Canada, even a Class I device, is a process built upon a foundation of regulatory compliance and ongoing responsibility. While Class I devices represent the lowest risk category within Canada’s regulatory framework, their oversight is far from passive. Safety and effectiveness requirements and all reporting obligations, as well as procedures that facilitate these activities, remain the same as for higher risk devices. These responsibilities ensure that all medical devices available on the Canadian market, regardless of risk classification, are subject to meaningful regulatory controls throughout their lifecycle. 

Understanding these responsibilities is not merely a bureaucratic exercise, it is a commitment to patient safety and product integrity. In future posts, we will explore the specific requirements for higher-risk device classes and the additional layers of evidence and review they require. Stay tuned as we continue our journey through the Canadian regulatory landscape.