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In Canada, the Medical Device Single Audit Program (MDSAP) will replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) within the next three years. On December 4, 2015, Health Canada published a notice addressing the transition plan.
According to this Health Canada Notice, regulatory quality management audits can be carried out according to either the current CMDCAS or MDSAP as of January 1, 2017. During the current pilot phase, Health Canada is already accepting MDSAP certificates instead of CMDCAS certificates. After expiry of the two-year transition period, i.e. as of January 2019, only MDSAP certificates will be accepted as part of device license applications or renewals.
MDSAP is aimed at developing a single regulatory audit of a medical device manufacturer’s quality management system that will be mutually recognized by several countries (at present Australia, Brazil, Canada, Japan and USA). The program was initiated in 2012 at the International Medical Devices Regulators Forum (IMDRF). The pilot phase was launched on January 1, 2014. TÜV SÜD has been authorized to perform MDSAP audits at medical device manufacturers since 2014, and was one of the first auditing organizations to gain this status.
Within the scope of regular TÜV SÜD audits, medical device manufacturers can already opt for a voluntary MDSAP audit. “Manufacturer participation is vital for the success of the program” was the conclusion of the recently published Mid-Pilot Status Report of the Medical Device Single Audit Program, given that the MDSAP – which is designed to achieve a more standardized and consistent approach by the auditing organizations – is also making the planning of market approval more reliable, and thus also offers significant benefits to manufacturers. If you are interested in participating in the MDSAP, please contact us.
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