Sep 11, 2015

A new mid-pilot status report on the international Medical Device Single Audit Program (MDSAP) identifies attracting more interest from manufacturers as the biggest challenge to meeting the pilot objectives and launching a fully-fledged single audit program.

Published on the US FDA’s website, the report notes that between August 2014 and July 2015, the number of manufacturer sites participating in the MDSAP pilot increased from only five to 45. Participating regulators in the US, Canada, Australia, Brazil and Japan tie the steady growth in numbers of manufacturers participating in the pilot to the increase in number of participating quality management system auditing organizations—more third-party auditors such as BSI Group and TÜV SÜD participating in MDSAP have drawn more interest from device manufacturers, in other words.

Manufacturer participation too low

However, one of the MDSAP pilot’s key proof of concept criteria states that the number of participating manufacturers should equal 10% of participating auditing organizations’ clients. (There are 13 auditors certified as Canadian Medical Device Conformity Assessment System or CMDCAS registrars that are eligible to participate in the MDSAP pilot.) The 10%b target means that 330 manufacturers subject to CMDCAS audits must participate in the program in order for this goal to be met. Regulators intend to launch the full MDSAP program in 2017, so need to boost manufacturer participation rates significantly between now and December 2016.

Not all CMDCAS registrars participating—yet

Of the 13 CMDCAS registrars identified as eligible to participate in the MDSAP pilot, six organizations have signed up as of July 2015, and have already undergone application reviews and assessments. MDSAP regulators expect that by the conclusion of the MDSAP pilot, all 13 organizations will have undergone these assessments.

Auditing organizations must perform witnessed audits as well as undergo surveillance assessments during the pilot, and achieve the following in order to be officially recognized under the full MDSAP program:

  • Successful application review
  • Completion of at least one certification assessment
  • Successful assessment by a MDSAP regulator during at least three witnessed audits of manufacturers
  • Successful technical review of assessment activities when the MDSAP pilot concludes

So far, two of the six auditing organizations currently signed up for MDSAP pilot participation have completed all of the above prerequisites.

Fully operational by 2016?

The report reaffirms regulators’ goal of establishing a fully operational MDSAP program by December 31, 2016, and also notes plans to accept applications from additional auditing organizations beyond CMDCAS registrars. Until then, however, MDSAP proponents’ work is cut out for them. Boosting manufacturer participation by hundreds of firms as well as ensuring that all 13 CMDCAS registrars meet their pilot requisites in roughly a year’s time will take some effort.


  • Stewart Eisenhart