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  Health Canada & MDSAP

Device manufactures who market in Canada should submit a valid MDSAP certificate to Health Canada by December 31, 2018. Some manufacturers face challenges scheduling an MDSAP audit in 2018 and delay in obtaining a certificate from the Auditing Organization, AO.

 

Health Canada will exercise enforcement discretion for those manufacturers who can demonstrate they have undergone an MDSAP audit in 2018, but do not yet have a certificate.

 

The announcement is available from https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program/certification-cycle-notice.html

 

 

 
 
 
 
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