21. August 2018

Health Canada is introducing a new structure for the submission of device license information of class III and IV products following the INDRF Guidance on nIVD(MA)ToC.

29. December 2017

Health Canada updates the guidance "Application for new medical devices"

31. October 2017

As announced by Health Canada in its document 17-112120-288 a reduction of the audit time for MDSAP audits is suitable for small organizations to the following extent: 10% for <45 FTE 20% for <15 FTE

04. August 2017

The transition periode for using the old ISO 13485:2003 will end on 2019-03-01