Single audit program for medical device QMS audits taking off

Manufacturer participation driven by requirement to use audit program for Canada from 2019

The Medical Device Single Audit Program (MDSAP) was conceived by the International Medical Device Regulators Forum (IMDRF) for the conduct of regulatory audits of quality management systems (QMS) as a result of the pressure on regulators and manufacturers from the sheer number of audits that have to be carried out.  While the audit duration for an MDSAP audit is longer than that for a single jurisdiction, the benefit should be a reduction in the number of separate audits that take place. Consequently, an individual regulator should have fewer audits to perform and a manufacturer experience less time being audited in aggregate.

MDSAP started as a pilot exercise in 2014 and became an operational program in 2017. Australia, Brazil, Canada, Japan and the USA are participating and the European Union and World Health Organization (WHO) are observers.  Although the EU are not participating members, when the Auditing Organization is also an EU Notified Body, they can also incorporate the European requirements into the audit. However, there is no doubt that the decision of Health Canada to replace the existing Canadian Medical Devices Conformity Assessment System (CMDCAS) and require an MDSAP audit to maintain Canadian Device Licenses after 31 December 2018 is leading to a rapid increase in use of the program.

The program combines into a single audit:

• ISO 13485,
• regulatory requirements for QMS from Brazil, Japan, Canada, Australia and the USA, with
• national requirements for registration, licensing, adverse event reporting and medical device tracking.

The audit uses a process approach, based on a foundation of risk management, to move through management controls, measurement, analysis and improvement, design and development control and production control. The audit also includes the application of purchasing control in each of these elements. The training material for MDSAP audits is available on the US FDA website under CDRH Learn ( go to Quality Systems – Inspections – Global Harmonisation).

If you supply devices to Canada and have not yet planned to transition to MDSAP, you need to start now to ensure continuity in supply of your medical devices to the Canadian market. If you have not already done so, start a discussion with your EU Notified Body to understand their involvement in MDSAP. There is material on the BSI website that can help you. 

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.