MDSAP Audit Times Reduced

In an October 31, 2017 notice, Health Canada that says the MDSAP Consortium has implemented changes to reduce the audit time. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html

The changes include:

  • Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time
  • Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees
  • Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees
  • Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers
  • Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.