The MDSAP: In Pursuit of Regulatory Harmonisation


Why create the MDSAP?

Since the foundation of the Global Harmonisation task force in 1993, medical device institutional bodies have been working to bring uniformity and simplicity to international accreditation, removing barriers to increased trade and improving patient access to emergent technologies. The Medical Device Single Audit Programme (MDSAP), another step on this path, is a system by which the Quality Management System (QMS) of a medical device manufacturer is audited with a view to satisfying regulatory requirements across multiple authorities. Participating authorities currently include:

  • Health Canada
  • Brazil (ANVISA)
  • Japan (MHLW/PMDA)
  • USA (FDA)
  • Australia (TGA)

Birth of the MDSAP

The MDSAP was conceived of at the Inaugural meeting of the International Medical Device Regulators Forum (IMDRF) (formally GHTF) in Singapore Feb 2012. The initiative drew on the spirit of harmonising adaptations being made to ISO:13485 by the same organisation. A work group was then formed to develop – ‘a standard set of requirements for auditing organisations performing regulatory audits for medical device manufacturers’ quality management systems.’

The FDA pilot programme for the MDSAP ran from January 2014- December 2016 assessing eight Proof of Concept Criterions (PoCCs). Though not all the PoCCs were met, (notably PoCC2, which set out that 80% of reports evaluated would substantiate a regulatory approval in each of the participating authorities. A figure of only 59% was eventually achieved) the overall pilot was deemed a success however, and the FDA deemed that it would accept MDSAP reports in lieu of agency inspections.

Anatomy of an MDSAP Audit

The audit falls into three sub-audits ran over a three-year period:

  • Initial Certification Audit
  • Surveillance Audit
  • Recertification Audit

The MDSAP audit follows a process approach as recommended by ISO. The audit begins with a thorough examination of SOPs, this takes the form of a questionnaire checklist, the content of which does not alter between different Auditing Organisations (AOs), the questionnaire can be requested ahead of time when the manufacturer has selected an AO.

The FDA website houses a 96-page ‘bible’ enabling manufacturers to adequately prepare for the MDSAP with a walkthrough of the expected activities and outputs of each component part. The table below is a numerical overview of each chapters’ activities and outputs, all of which must be addressed.

Chapter Outcomes Tasks Links
Management 9 11 7
Device Marketing Authorisation & Facility Registration 4 3 4
Measurement, Analysis and Improvement 6 16 10
Medical Devices Adverse Events and Advisory Notices Reporting 3 2 3
Design and Development 9 17 7
Production and Service Controls 6 29 9
Purchasing 5 12 7

 Figure 1: Taken from the FDA MDSAP ‘bible’

Below is a top-level summary diagram of the component parts included in the audit, though there is no requirement for the stages to run uniformly in this order for each manufacturer, AOs tend not to deviate from this structure to enable the information used to flow logically from one component part to the next, easing decision making processes and overall grading assignment.

Figure 2: The MDSAP Audit diagram

In summary

The MDSAP forms a small part of what is a regulatory revolution in medical devices. Developments in supply chain, technological innovation, and continuing improvements in patient access to information have created a growing need for manufacturers and institutions to reflect this new era in device development regulations.

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