Nov 5, 2013

Canadian medical device market regulators have provided more details about their participation in the international Medical Device Single Audit Program (MDSAP) pilot set to begin in 2014 in Canada, the US, Brazil and Australia.

Health Canada plans to run the MDSAP pilot in parallel with its current Canadian Medical Devices Conformity Assessment System (CMDCAS) program for quality management system audits. The regulator plans to accept MDSAP audit certifications the same way it does for CMDCAS.

According to Health Canada, the MDSAP pilot will last for three years, after which Canadian regulators plan to transition their quality system audit processes fully from CMDCAS to the MDSAP. For manufacturers marketing their devices only in Canada, Health Canada would assess only quality system components required under Canadian law.

Finally, only registrars currently recognized by the CMDCAS program will be considered for participation in the MDSAP pilot. Once the pilot ends, additional auditing firms will be able to apply for recognition under the MDSAP in Canada.

Stewart Eisenhart


  • Stewart Eisenhart