Health Canada Readies Transition Plan for Full MDSAP Implementation
Canadian medical device market regulators have announced plans to transition fully to an international quality system audit program, the Medical Device Single Audit Program or MDSAP, once the pilot phase of the program ends in December 2016.
Health Canada plans to undertake full MDSAP implementation starting in January 2017, and to replace the country's existing Canadian Medical Devices Conformity Assessment System (CMDCAS) with MDSAP as the process to determine quality system compliance of device manufacturers licensed to market their products in the country. Health Canada expects the implementation to last two years.
(As a reminder, the MDSAP program entails participating regulators (The US FDA, Brazilian ANVISA, Health Canada, Australian Therapeutic Goods Administration and the Japanese Pharmaceuticals and Medical Devices Agency recognizing quality system audits performed in any one of their participating jurisdictions as sufficient to meet one another’s quality system requirements.)
Until the MDSAP implementation is complete, Health Canada will accept certificates issued either via CMDCAS or MDSAP auditing routes as proof of compliance with Canadian quality management system requirements. Starting on the anticipated date of January 1, 2019, Health Canada will only accept MDSAP certificates.
All companies currently signed up as CMDCAS registrars have stated their intentions to apply for MDSAP authorization, but Health Canada recommends that manufacturers verify that their registrars do indeed plan on seeking MDSAP authorization ahead of full implementation.
Although not all participating MDSAP regulators have yet disclosed their implementation plans, Health Canada’s announcement shows that device manufacturers will be able to leverage their quality system certifications from US, Brazilian, Australian and/or Japanese authorities in order to access the Canadian market.