Canada: Updates to Medical Devices Regulation

 

Canada has published Regulations Amending the Medical Devices Regulations.

This proposal implements Phase II of Health Canada’s commitments outlined in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enhancing oversight to better address emerging health and safety risks.

The proposed amendments would:

• Remove the requirement for importers holding an MDEL to source products only from foreign distributors with an MDEL.
• Require all MDEL applicants to provide supplier information as part of their application and to update this information annually during licence review.
• Clarify the obligation for manufacturers, importers, and distributors to establish, implement, and maintain documented procedures relevant to their safety management activities.

Most medical devices sold in Canada are imported, with an increasing number of suppliers entering the Canadian market. Combined with regulatory flexibilities trialed during the COVID-19 pandemic, this highlights the need to update the MDEL framework, enabling Health Canada to continue providing efficient, effective, and agile oversight of medical devices and ensuring the protection of public health and safety in Canada.

To find out more about compliance for medical devices, do not hesitate to contact the Product Compliance Institute.