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.
Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug Administration has provided additional information on its planned participation in the pilot.
Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.
Participating regulators—the Australian Therapeutic Goods Administration (TGA), Brazil’s ANVISA, Health Canada and the US Food and Drug Administration—ultimately hope to develop the MDSAP into a system whereby medical device manufacturers undergo only one quality management system audit acceptable across multiple regulatory jurisdictions. Currently, device manufacturers have to show compliance with different quality system standards such as FDA Quality System Regulations in the US, ISO 13485 in Europe and Brazilian Good Manufacturing Practices (BGMP) in order to register their products in those markets.