Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.

The goal of the MDSAP is to provide for more effective, efficient, and less burdensome regulatory oversight of the quality management system of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the Participants.

Source: Statement of Cooperation, Medical Device Single Audit Program, FDA/ORA/Office of Medical Products and Tobacco Operations

So in 2014, the U.S. FDA, along with the regulatory bodies of Australia (TGA), Brazil (ANVISA), and Canada (Health Canada), launched the MDSAP three-year pilot program, allowing recognized third-party auditors to conduct a single audit of a device manufacturer that would be recognized internationally. One year later, Japan’s regulatory agencies (MHLW and PMDA) joined the pilot program as well.

In the coming months, you’re likely to hear an increasing buzz about MDSAP as the pilot program wraps up and the world’s medical device manufacturers get ready for its full-scale global implementation. It’s a good time to review the program’s origins and current pilot status, and to consider the potential implications of a unified, international approach to auditing and monitoring medical device manufacturers.

Flight Plan: Why Establish a Global Auditing Platform?

International regulators have long recognized the value of developing a standardized, global approach to auditing and monitoring medical device manufacturing. In designing the MDSAP, one of the IMDRF’s stated objectives is “to promote greater alignment and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority.”

Additional objectives include:

• Operate a single audit program that provides confidence in program outcomes;
• Enable the appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry;
• Promote, over the longer term, greater global alignment of regulatory approaches and technical requirements based on international standards and best practices;
• Promote consistency, predictability and transparency of regulatory programs by standardizing oversight practices and procedures of Participants over third-party auditing organizations, and the practices and procedures of participating third-party auditing organizations. (Source: www.fda.gov)

The MDSAP program basically uses ISO 13485:2003 as a framework, in addition to Good Manufacturing Practice (GMP) requirements of the various regulatory authorities. For instance, the U.S. is also including 21 CFR Part 820, which is their Quality System Regulation, and Brazil is requiring elements of RDC ANSVISA 16/2013, which is their Good Manufacturing Practices guidance, while each country’s Post-Market reporting will uniquely be reviewed as well.

Passenger Perks: Why Participate in the MDSAP Pilot Program?

Prior to launch, the IMDRF communicated the key benefits to the program:

• May be an acceptable alternative to inspection required for marketing authorization in some countries. For example, Brazil is using the MDSAP certification process as a way to expedite a Medical Device Company’s product approval process to help a company sell into Brazil faster if they use the MDSAP process;
• Reduced burden on manufacturer resources, by reducing the number of regulatory inspections/audits from as many as four per year (now five per year, including Japan) to one per year. In the U.S., the FDA is accepting the MDSAP audit reports as a substitute for FDA routine inspections;
• Common audit criteria capturing the requirements of all participating regulatory authorities to be used by recognized auditing organizations;
• Predictability in outcome, based on the use of a standardized non-conformity grading system. (Source: www.IMDRF.org)

In practice, pilot participants are also recognizing that combining audits is a clear money, time and human resource saver, especially for larger device manufacturers that sell products internationally and that may be subject to numerous lengthy inspections as a result of their size and operations. Additionally, because MDSAP audits are scheduled months in advance, manufacturers are able to set aside the time and resources necessary for a successful audit.

One Passenger’s Log Book: The Arthrex Experience

Arthrex, a global medical device company and leader in new product development and medical education in orthopedics, was the very first device manufacturer to sign on as a participant in the MDSAP pilot program in 2014. Why did they choose to get into the program at the outset?

“In general, audits are distracting and time-consuming, and you have to plan for each country where you do business to come in individually to conduct their own audits,” said Barry Dietz, Global Director, Quality Assurance and Regulatory Affairs, at Arthrex. Since it joined the MDSAP Pilot, Arthrex has already experienced the efficiencies of a reduced audit schedule.

“We were pleasantly surprised (about the process),” Dietz said. “Under the MDSAP, we have only one scheduled audit per year, and they are fairly straightforward. They cover ISO 13485 requirements and MDSAP quality system regulations at the same time.”

Arthrex also experienced an unannounced audit to satisfy European ISO13485 requirements. “The auditors that conducted the unannounced audit were very focused and proficient.”

While the regulatory requirements are not new, a structured and integrated audit approach requires organizations to look comprehensively at all of the participating countries’ requirements to ensure those standards are fully embedded within their own quality systems.

“There’s no reason to fear these new comprehensive audits as long as you’re prepared and doing the right thing,” said Dietz.

Flight Status: How is the Pilot Performing?

While the willingness of device manufacturers to sign on as pilot MDSAP participants was slow to start, at last count, there were 45 medical device manufacturing sites participating in the pilot. Six approved auditing organizations, including BSI and TÜV SÜD, have been certified to conduct MDSAP audits anywhere in the world.

The pilot has been running in accordance with the actual operational program. Audits are conducted annually, according to a three-year certification cycle, by approved auditing organizations. All MDSAP audit reports must be submitted to all regulators. As part of the program, regardless of the outcome, all regulators will be reviewing the reports.

According to Arthrex’s Dietz, the MDSAP audit protocols are not that different, but he recognized modifications to the audit criteria and scoring. A standardized non-conformity grading system was introduced, as citing only major or minor non-conformities does not provide sufficient detail for global information exchange.

“By participating in MDSAP, you give the auditing bodies more confidence in your operations because you’re clearly trying to do the right thing and not circumvent the system.”
Barry Dietz, Global Director, Quality Assurance and Regulatory Affairs, Arthrex

Time is flying and the pilot program is now on its final approach to the scheduled conclusion: Dec. 31, 2016. Participating regulatory bodies have demonstrated international cooperation in expediting the global audit program, which to date, has been running smoothly. And according to feedback that BSI shared with Arthrex, “feedback about the benefits has been overwhelmingly positive.”

Cleared for Takeoff: Expectations for the Full-Scale Launch

It’s expected that the “official” MDSAP will be fully operational in 2017 and become the standard way of doing business with global regulators. Each regulator within the consortium has committed to continuing to use MDSAP audits going forward. It is also hoped that the European Union, which has been only an observer throughout the pilot period, will join the program in 2017.

It’s also noteworthy that Health Canada is mandating that by January 2019, all Medical Device companies that sell product into Canada must have a MDSAP certification, replacing the Canadian Medical Devices Conformity Assessment System (CMDCAC), or they will not be able to continue to sell product there.

Whether a medical device manufacturer is facing an MDSAP audit, or in the meantime, any other type of regulatory audit, it’s important to recognize that effective audits are the foundation for quality and compliance throughout your organization.

Pilgrim Quality Solutions appreciates that establishing an effective audit management system can be challenging, and that’s where SmartSolve^® Audit Management comes in. This solution can support the necessary planning, management, and execution of quality and regulatory audits to keep device manufacturers sailing through clear skies.