Canada: Medical Device License Amendments

Welcome back to MedTech Compliance Chronicles! As we have already discussed, in Canada, manufacturers of Class II, III, and IV medical devices must hold a Medical Device License before selling their device. However, once a device has been licensed by Health Canada, the license must accurately reflect the device as it exists on the market. Any changes that may affect its design, performance, safety, or intended use must be carefully evaluated to determine whether they require Health Canada’s review and formal approval through a license amendment.

These amendment requirements are set out in the Canadian Medical Devices Regulations (CMDR) and are intended to ensure that all licensed devices continue to meet the same standards of safety and effectiveness that supported their original approval. This post will explain how to identify which changes require a medical device license amendment in Canada. It will begin with a discussion of significant changes, followed by an overview of other changes that also trigger amendment requirements for all device classes.

Significant Changes

Under Section 34(a) of the CMDR, manufacturers of Class III and Class IV medical devices are required to apply for a license amendment before making any significant change to their device. A “significant change” is defined as a modification that could reasonably be expected to affect the safety, effectiveness, or quality of the device. Health Canada requires prior review and approval of these changes to ensure that the modified device continues to meet the same regulatory standards that supported its original licensing. Significant changes can occur across several dimensions of a device’s lifecycle, including its design, materials, manufacturing process, performance specifications, or intended use. 

When it comes to the device itself, significant changes commonly fall into two primary areas: the core device function and its intended use. Any change to the core function or specification that could impact clinical outcome is considered significant. Examples include altering an algorithm that controls therapy delivery, changing the device's fundamental operating principle (manual to software-controlled), changing the device’s power source (internal battery to mains supply power) or adding a new feature that affects patient data interpretation. Finally, changes to materials or components that come into direct or indirect contact with the patient or body fluids are often deemed significant because they may affect biocompatibility, durability, or performance. Note here that all changes in the source of materials of animal origins are considered significant. 

Modifications to the device's intended use, are among the most critical forms of significant change. Changes to the intended use could include expanding the conditions or patient population for which the device is used. For example, expanding the indication to include a new disease state or changing the target user from a medical professional to a lay-user for home use, triggers the amendment requirement. These types of changes require new supporting data, such as clinical evidence or risk analyses, to demonstrate safety and effectiveness under the newly included use conditions.

Manufacturing and quality control process changes can also meet the threshold for significance if they affect the assurance of safety and efficacy. For instance, any modifications to the sterilization process, critical process parameters or acceptance criteria are generally considered significant. Even changes in suppliers can be considered significant, particularly when the supplier is a subcontractor for a critical process, such as sterilization.

Other Changes Requiring License Amendment

Beyond significant changes, several other types of modifications to medical devices require a license amendment under the CMDR. These changes may not directly affect a device’s safety or effectiveness but still alter key information contained within the original license application. Health Canada requires that these updates be reviewed and approved to ensure that all licensing records remain current and accurate.

Administrative changes are among the most common reasons for license amendment. A change to the manufacturer’s name or address, or to that of the regulatory correspondent, requires Health Canada’s authorization. Similarly, updates to the device name or brand name must be submitted through a license amendment application to ensure that the marketed device can be properly traced and identified under its approved license. 

For Class II devices, which are not subject to the “significant change” definition, any change to the intended use or medical conditions for which the device is marketed still requires a license amendment. For example, if a Class II diagnostic kit originally approved for one disease is expanded to cover another, the manufacturer must submit an amendment with updated labeling and supporting evidence. For other design or manufacturing changes to Class II devices that do not affect intended use or risk class, Health Canada does not explicitly require a license amendment. These changes can be managed through the manufacturer’s quality management system, provided they do not introduce new risks or performance characteristics. However, manufacturers are expected to perform internal assessments and maintain documentation to demonstrate continued compliance. Additionally, any changes to any class of device that could affect its classification requires a license amendment, or, in the case of a class I device changing to a higher classification, a new license application.

In borderline cases, Health Canada may allow certain updates to be submitted via simplified “fax-back” forms, especially for administrative changes or additions of new models within an existing license scope. Ultimately, any change that alters the device’s regulatory identity or its approved use must be reviewed and approved by Health Canada through the license amendment process.

Conclusion

Mandatory reporting obligations of adverse events and changes are among the most critical aspects of post-market regulatory compliance in any jurisdiction. In Canada, reporting of changes comes in the form of license amendments. Health Canada expects manufacturers to treat the medical device license as a living document, one that accurately represents the device as it is currently designed, manufactured, and marketed. For Class III and IV devices, this means identifying and reporting significant changes under Section 34(a). For all device classes, it includes submitting amendments for updates to names, addresses, labeling, or certification that alter the information originally approved by Health Canada.