Health Canada Transition to MDSAP

OMEDtechNews & Events

Health Canada has announced that they are in the process of changing from CMDCAS to MDSAP for medical device manufacturers to sell products in Canada.  The Medical Device Single Audit Program (MDSAP) pilot is regulatoryongoing and was created to have a single audit meet the quality management system requirements of multiple agencies based on ISO 13485:2003.  The switch to MDSAP will take place over a two year period, beginning at the conclusion the pilot on January 1, 2017.  Throughout the transition Health Canada will accept certificates from CMDCAS and MDSAP.  Medical device manufactures who wish to sell in Canada are encouraged to make the transition to MDSAP for their next CMDCAS audit.  By January 1, 2019 Health Canada will only accept MDSAP certificates.
For more information on the Health Canada transition from CMDCAS to MDSAP see the following: