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Health Canada will terminate the CMDCAS program on December 31, 2018. After this date Health Canada will only accept MDSAP certificates from manufacturers with their device applications or renewals. To facilitate uninterrupted market access TÜV SÜD will no longer be conducting CMDCAS audits as of September 30, 2017, and all audits for Health Canada after this date shall be carried out under the MDSAP program. Additionally, TÜV SÜD experts now offer support for the transition of existing certificates.
It is recommended to CMDCAS certificate holders to plan now how to proceed further. They can choose between the following Options::
The Medical Device Single Audit Program (MDSAP) will replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) within the next two years. From January 2019 Health Canada will only accept MDSAP certificates.
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). 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.