Monthly Archives: October 2016

Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

By |October 18th, 2016|

Currently, disinfectants and sterilants that are intended for use on medical devices are regulated as drugs under the Food and Drug Regulations. However, Health Canada has communicated that they intend to reclassify these products as medical devices which means that disinfectants and sterilants used on medical devices would be subject to the requirements of the […]

Transition to ISO 13485:2016

By |October 4th, 2016|

ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016.

All Canadian and Foreign manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1, 2019.

Manufacturers which have not transitioned to ISO […]