Health Canada publishes new guidelines on the use of technical standards to demonstrate compliance with the Medical Devices Regulations

Health Canada published, in January 2025, a new guidance document on the use of recognized standards as support to demonstrate compliance with the requirements of the Medical Devices Regulations (Canadian MDR).

The document provides clear guidance to manufacturers on how to rely on recognized national and international standards in the context of submitting new or amended licenses for Class II, III, and IV medical devices, as well as for special access authorizations, investigational testing, or custom-made devices.

Regulatory context

The Medical Devices Regulations require that all medical devices placed on the Canadian market comply with requirements related to:

• safety and effectiveness (sections 10 to 20);

• labeling (sections 21 to 23).

Since these requirements are stated in general terms, the use of technical standards allows for consistent interpretation and facilitates the process of demonstrating compliance. Health Canada’s List of Recognized Standards (which is updated periodically) provides a reference for manufacturers in choosing applicable standards.

Key aspects of the new guidance

• Recognized standards may be used as partial evidence of compliance in licenses or authorizations;

• Compliance with standards is voluntary, but if a manufacturer chooses to use a non-recognized standard or an outdated version, they must provide detailed technical evidence and appropriate justifications;

• The guidance clarifies the required content of the Declaration of Conformity to be submitted with license or authorization applications;

• Changes in standard versions: when a standard is updated, Health Canada establishes a 3-year transition period for manufacturers to adapt — unless otherwise specified;

• Record keeping: manufacturers must retain all supporting documentation, including test data and declarations of conformity, for a minimum of 2 years or until the end of the device’s useful life.

Limitations of recognized standards

Health Canada warns that not all aspects of a device’s safety and effectiveness may be covered by recognized standards — particularly in the case of emerging technologies. Therefore, it may be necessary to complement documentation with additional data (e.g., clinical studies, tests not covered by standards).

How Smart MDR can support manufacturers

Smart MDR helps companies that aim to:

• Submit medical devices to the Canadian market;

• Prepare or review Declarations of Conformity according to recognized standards;

• Manage the lifecycle of standards and ensure that updates and transition periods are correctly implemented;

• Reduce risks of non-compliance during Health Canada audits or inspections.

If your company markets or intends to export medical devices to Canada, contact us.