Jan 19, 2015

Canadian medical device market regulators have begun soliciting manufacturers to participate in a pilot version of a nascent international quality management system auditing program, the Medical Device Single Audit Program or MDSAP.

Launched officially in January 2014, the MDSAP pilot is designed to allow manufacturers in participating countries to undergo single quality system audits that will meet requirements of all participating regulators—the US Food and Drug Administration, Health Canada, ANVISA in Brazil and the Australian Therapeutic Goods Administration.

Using an Auditing Organization authorized by all MDSAP participating regulators, pilot participants can obtain one audit to meet requirements of ISO 13485, Brazilian Good Manufacturing Practices, US Quality System Regulations under 21 CFR Part 820 and other quality system requirements specific to Canadian and Australian regulators.

The pilot will run for three years, during which Health Canada will still conduct Canadian Medical Device Conformity Assessments (CMDCAS) in parallel with the MDSAP program, and will accept certification from either source for Class II, III and IV device licenses.

Additional information on medical device registration and CMDCAS can be found in our video overview of the Canadian market.


  • Stewart Eisenhart