Health Canada’s Notice on the Medical Device Single Audit Program

Author: Pinky Mazumder 

Late last year, Health Canada issued a notice to the industry on the reduction of audit times for the Medical Device Single Audit Program (“MDSAP”).

The MDSAP, introduced by the International Medical Devices Regulators Forum in 2012, seeks to harmonize a single audit of medical devices to meet the Quality Management System requirements for more than one regulatory agency. The objective is to reduce regulatory burdens and align the regulatory requirements across various agencies. Previously, manufacturers were required to comply with the Canadian Medical Devices Conformity Assessment System (CMDCAS) and submitted their issued CMDCAS certificates to Health Canada. Per the MDSAP transition program, Health Canada currently accepts both CMDCAS certificates as well as MDSAP certificates, however starting January 1st, 2019, Health Canada will only accept MDSAP certificates.

In the Notice, Health Canada encourages manufacturers to ensure that corresponding Auditing Organizations schedule a transition as soon as practicable. Manufacturers who fail to transition before January 1st, 2019 could face compliance actions and even the cancellation of their medical device licenses. The Notice also mentions that comments were received from license holders which led to the MDSAP Consortium to make the following changes:

-  To reduce the overall time required for audit and reduce the number of tasks,    the MSDAP audit approached has been streamlined in the revision of the audit    model.

-  For manufacturers with 45 employees or less, the audit time is to be reduced    by 10%

-  For manufacturers with 15 employees or less, the audit time is to be reduced    by 20%

-  The duration of surveillance and re-certification audits are to be reduced by    20% for all manufacturers

-  With the purpose to reduce audit time, the expectations for annual    surveillance audits have been clarified

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 References

1. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html

2. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/notice-transition-plan-medical-device-single-audit-program.html