Canada: Updates to the medical devices regulation 

 

Canada has published updates to its medical devices regulation: Regulations Amending the Medical Devices Regulations (Establishment Licences). 

The amendments to the Medical Devices Regulations (MDR) are intended to modernise the Medical Device Establishment Licence (MDEL) framework to better reflect an increasingly innovative medical devices sector while maintaining effective regulatory oversight to address emerging health and safety risks. They aim to reduce unnecessary regulatory burden, facilitate international regulatory alignment, strengthen Health Canada’s ability to identify and monitor non-compliant medical devices and establishments that may pose risks to health, and provide greater clarity and certainty regarding the requirements of the MDR. The amendments also support the Government’s red tape reduction objectives and reinforce a risk-based approach to regulation. 

The amendments remove the requirement for importers holding an MDEL to source medical devices only from foreign distributors that also hold an MDEL. A licensed importer in Canada provides sufficient oversight to ensure the traceability of medical devices where safety or quality concerns arise. Persons importing medical devices without holding an MDEL, including retailers and health care facilities, will continue to be required to verify that the foreign distributor from whom they import holds an MDEL. This change reduces unnecessary duplication within the current licensing framework and brings the Canadian regime more closely into line with those of comparable jurisdictions. 

To maintain appropriate regulatory oversight, the amendments require all MDEL applicants to provide information on their foreign suppliers as part of the licence application process and to update that information annually during the licence review. This will enable Health Canada to undertake more targeted and effective compliance and enforcement activities by maintaining visibility over foreign distributors that are no longer required to hold an MDEL when supplying medical devices through an MDEL holder. 

The amendments also clarify the obligations of manufacturers, importers and distributors by expressly requiring them to establish, implement and maintain documented procedures relevant to their safety management activities. This responds to compliance and enforcement issues identified by Health Canada during inspections and helps ensure that health and safety risks are effectively managed throughout the period during which a medical device is placed on the market. 

To find out more about product compliance in Canada and compliance for medical devices, please do not hesitate to contact us directly.