With the latest update of the list of recognized standards (for 2019), Health Canada has eliminated eight standards and added fourteen new ones.

Updated list of recognized standards for Medical Devices in Canada

The new list of recognized standards came into force officially on February 25, 2019.

In addition to adding and deleting, Health Canada has substantially updated thirteen standards, including:

  • IEC 62304:2015 regarding software life cycle processes of medical device software, and
  • IEC 60601-1-3:2013, IEC 60601-2-37:2015, IEC 60601-2-44:2016 e IEC 60601-2-54:2015 on electromedical equipment.

Furthermore, with regard to electromagnetic compatibility, effective December 31, 2018, compliance with the IEC 60601-1-2:2007 – 3.0 Edition standard is no longer accepted by the Canadian regulatory Authority, the fourth edition having become effective on the said date.