The Medical Device Single Audit Program (MDSAP) was initiated at the International Medical Devices Regulators Forum’s (IMDRF) inaugural meeting in Singapore in 2012.
The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2003. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits. In addition to Health Canada, the participating agencies are the Australian Therapeutic Goods Administration (TGA), the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), the Japanese Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the United States Food and Drug Administration (FDA).
The Pilot is scheduled to conclude December 31, 2016, and as stated in Health Canada Notices dated January 2014 and January 16, 2015, Health Canada intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Devices Regulations (the Regulations). MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the Pilot on January 1, 2017, and will span a period of two years. During this two years’ period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted. Further details will be released as the transition plan is finalized. Health Canada’s transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485, which is anticipated to be published in early 2016.