In vitro diagnostic (IVD) and medical device manufacturers must transition to the Medical Device Single Audit Program (MDSAP) before January 1, 2019 in order to continue trading on the Canadian market.
Health Canada will end its Medical Devices Conformity Assessment System (CMDCAS) and only accept certificates issued under the MDSAP, an initiative whereby manufacturers are audited once for compliance with the standard and regulatory requirements of one or more of the following countries: Australia, Brazil, Canada, Japan and the United States. Manufacturers that obtain MDSAP certificates will meet the quality management system requirements of the Medical Devices Regulations
Licences already obtained using a CMDCAS certificate will be subject to suspension if they are not supported by a valid MDSAP certificate after the deadline. For manufacturers that only sell products in Canada, the regulatory requirements of the other MDSAP participating countries will not be audited. Contact us
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