Uncovering the Medical Device Single Audit Program

By Peter Rose

With the ever-evolving regulatory landscape, it’s challenging for medical device manufacturers to know which changes to prioritize first. One of the industry’s most recent innovations? The Medical Device Single Audit Program, or MDSAPInternational regulators have long advocated for a global approach to monitor the manufacturing of medical devices, and with that, the International Medical Device Regulators Forum launched the MDSAP.

The vision of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple jurisdictions. The idea is that the program will mimic the FDA Quality System Inspection Technique. Therefore, the MDSAP is promoting the greater alignment of regulatory approaches and technical requirements, in addition to calling for across-the-board consistency, predictability, and transparency of regulatory programs.

The international coalition of authorities participating in the pilot includes the U.S. FDA, the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the Ministry of Health and Labour and Welfare of Japan.

Even so, there appears to be a distinct lack of guidance for manufacturers and other industry stakeholders regarding the MDSAP. Fortunately, the information below will shed light on the program and explain the business advantages that can be gleaned from it.

Overall Scope of MDSAP

Back in 2014, the participating countries of the MDSAP commenced a trial of the single-audit program—and, in June 2017, a report was collated combining the “proof of concept” criteria established to confirm the viability of MDSAP.

The MDSAP is structured into seven different processes: management; device marketing authorization and facility registration; measurement analysis and improvement; medical device adverse events and advisory notices reporting; design and development; production; and service controls and purchasing.

Further, the International Medical Device Regulators Forum document, Audit Model MDSAP AU P0002, contains the relevant instructions for the planning and implementation of the audit process for MDSAP. It also includes an audit sequence and specific instructions for auditing each process.

MDSAP by Nation

There are specific aspects that manufacturers selling their products in each of the five counties involved in the MDSAP should consider

  • Australia: The MDSAP accepts combination products and other medical devices. Further, the TGA can accept MDSAP certificates as support of evidence for compliance with the ISO 13485 standard, although additional documents may be requested.
  • Brazil: An August 2015 resolution allows MDSAP reports as an alternative to an ANVISA inspection if the previous ANVISA inspection was deemed satisfactory.
  • Canada: Starting on Jan. 1, 2019, Canada’s Class II, III, and IV medical devices will follow the MDSAP. The Canadian Medical Devices Conformity Assessment System will be transferred to the MDSAP. In contrast to the other partners of the program, in which participation is voluntary, the MDSAP will be mandatory for regulatory submission in Canada.
  • United States: The MDSAP can be an alternative to an FDA inspection, excluding combination products and premarket approval inspections. Moreover, certification documents issued by the auditing organization (AO) must comply with applicable U.S. regulations.
  • Japan: An MDSAP audit report submitted at the time of pre- or post-market quality management system (QMS) inspections can be used as a trial to exempt some manufacturing sites from onsite inspection and/or to allow the manufacturer’s marketing authorization holder to substitute the MDSAP report for a considerable part of documents required for the inspection.

How the Audit Works

Implementation of the MDSAP typically takes three years and consists of three different audits:

  1. Initial audit: The stage 1 audit is a documentation review, which analyzes and determines the readiness for the audited company to undergo a stage 2 audit. This is followed by the stage 2 audit — an implementation review of the ISO 13485 standard and regulations applicable to the participating countries. The idea is that it will review the QMS in order to verify whether the products are safe, effective, and meet performance specifications.
  2. Surveillance audit: If no substantial changes have occurred since the last audit, then a stage 1 audit does not have to be executed. The intention of the surveillance audit is to maintain confidence in the compliance of the audited QMS with applicable standards and regulations.
  3. Recertification audit: Again, a stage 1 audit is not mandatory as the premise of the recertification audit is to evaluate the effectiveness and sustainability of the QMS in order to satisfy all standards and regulations. Secondly, it is to confirm the relevance and applicability of the QMS, with the scope of certification and MDSAP-specific requirements.

The Benefits of MDSAP

The MDSAP covers the existing ISO 13485 standard and country-specific requirements, which means the normative and regulatory frameworks remain unchanged. This also means that medical device manufacturers benefit from an effort of standardization and harmonization within the QMS, and also in the regulatory submissions.

Moreover, the MDSAP is formulated on multiple regulations from five participating countries, which means manufacturers will automatically comply with those nations’ regulations; this then eliminates the challenge—as well as time-constraints—of preparing for audits and inspections within multiple markets.

Such a change also allows manufacturers to broaden their participation in the markets that are included in the MDSAP. And in terms of providing market advantages, the MDSAP might be seen as evidence of a medical device manufacturer’s commitment to product quality and regulatory compliance; some may, in fact, use it as a tool to stand out in a crowded marketplace.

Finally, implementing the MDSAP enables manufacturers to collaborate with external resources, such as MDSAP subject-matter experts, who will contribute timely and valuable support for the MDSAP audit preparation. In other words, take note, manufacturers: Collaborating with an MDSAP expert will help you navigate the best path to success.

Pitfalls to Avoid

One potential drawback is that there may be a lack of trained internal auditors within a manufacturer’s organization. This means that manufacturers will need to train their in-house auditors and other employees regarding the methods and criteria of a MDSAP audit. Yes, this will temporarily incur additional costs; however, this redeployment of resources should be viewed as a mandatory constraint, which will eventually provide the manufacturer with new opportunities.

Also, the industry will be initially impacted since only three AOs are currently recognized to conduct MDSAP audits, and only 11 AOs are authorized to do so. These AOs are already acting as notified bodies in Europe, which means their capacity to handle manufacturers’ increased requests for MDSAP audits will be strained—especially since the new European Medical Device Regulation and in vitro diagnostic product regulation will go into effect in the next few years.

Measuring MDSAP Success

When determining whether the MDSAP has been successful, consider these eight key performance indicators:

  1. The content of the audit reports conforming to the requirements
  2. Consistency of the audit findings and supporting evidence
  3. Sufficient information in the audit report to provide to the regulatory authorities
  4. Any gaps between the audit model
  5. The QMS and regulatory requirements
  6. The task sequence and assessment model that determines MDSAP requirements—an appropriate audit duration
  7. The number of recognized AOs
  8. The number of manufacturers participating in the MDSAP

Summing It Up

The MDSAP involves various stakeholders, all of which have different roles, responsibilities, and levels of influence. Even so, the MDSAP is a single auditing program that unifies stakeholders in a collaborative effort for the overall benefit of the medical device industry.

What’s more, it’s clear that the MDSAP will significantly reduce the work for manufacturers and AOs, who work in or with one of the five countries that have piloted the program. The main benefit of having to comply with a single audit program across multiple countries: Everyone will be working from a unified action plan.

In summation, even though the implementation phase of the MDSAP may initially appear to be cumbersome, the benefits of the single audit program will supersede the constraints.

Peter Rose is managing director for Europe at regulatory consulting company Maetrics. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected]