Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a manufacturer’s quality management system, refusing to accept audit reports from the same facility prepared for submission to a regulatory authority in another jurisdiction.
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The need for duplicate pre- and post-market audits becomes an expensive proposition for manufacturers, and can slow the introduction of new and innovative medical devices around the world. To address this, in 2012 the International Medical Device Regulators Forum (IMDRF) established a working group to create the Medical Device Single Audit Program (MDSAP).
The MDSAP’s objective is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization (AO), which will satisfy the needs of multiple regulatory jurisdictions. (AOs are known as certification bodies in other certification schemes.) This article provides a summary of the MDSAP pilot program and discusses how it can help medical device manufacturers.
What is the IMDRF?
The IMDRF is a voluntary group of national regulators from around the world. The IMDRF’s stated goal is to “accelerate international medical device regulatory harmonization and convergence.” Current IMDRF management committee membership includes representatives from medical device regulatory authorities in the following countries:
• Australia (Therapeutic Goods Administration—TGA)
• Brazil (National Health Surveillance Agency—ANVISA)
• Canada (Medical Devices Bureau of Health)
• China (China Food and Drug Administration)
• European Union (Commission Directorate General Health and Consumers)
• Japan (Pharmaceuticals and Medical Devices Agency—PMDA)
• Russia (Ministry of Health)
• United States (U.S. Food and Drug Administration)
Participants in IMDRF discussions also include representatives from the Asian Harmonization Working Party (AHWP), a complementary body to the IMDRF that covers more than 20 additional national economies, as well as the Regulatory Harmonization Steering Committee of the Life Sciences Innovation Forum of the Asia-Pacific Economic Cooperation (APEC).
What is the MDSAP initiative and pilot audit program?
The MDSAP initiative is currently headed by Kimberly Trautman, associate director for international affairs at the U.S. FDA’s Center for Devices and Radiological Health. In January 2014, the MDSAP Regulatory Authority Council (RAC) Pilot Consortium initiated the pilot program, which is expected to extend for a three-year period through the end of 2016. The pilot MDSAP program involves four regulatory authorities, namely the U.S. FDA, Health Canada, Australia’s TGA, and Brazil’s ANVISA. Japan has been an official observer and active participant in the pilot program. The Japanese have not clearly indicated when they will participate in the program, however, Japan will be the chair of the MDSAP next year. Under the terms of the pilot program, participating regulatory authorities will accept audit reports of medical device manufacturers’ quality management systems based on audits conducted by authorized AOs. Audits will be based on the requirements of ISO 13485—“Medical devices—Quality management systems—Requirements” for regulatory purposes, as well as any country-specific requirements of medical devices of those regulatory authorities participating in the pilot program.
The four regulatory authorities participating in the MDSAP pilot program have some discretion regarding the acceptance of audit reports from other pilot program participants. Some specific national conditions include:
Australia: The TGA will accept MDSAP audit reports as part of the evidence reviewed for a determination of compliance with its market authorization acceptance criteria, except in those cases where specific TGA policies restrict the use of such audit reports.
Brazil: Class III and IV device applications need a GMP certificate issued by ANVISA. ANVISA can issue a GMP certificate based on their audit or an MDSAP AO audit report for certain initial audits and surveillance audits. There is a multiple-year backlog for ANVISA to conduct their own audits.
Canada: Health Canada will use MDSAP audit reports as part of its CMDCAS certification program, and is expected to use MDSAP reports as evidence of compliance with quality management systems requirements following the conclusion of the pilot program.
United States: The U.S. FDA will accept MSDAP audit reports as a substitute for FDA routine inspections. However, inspections for pre-market approval projects of class III high-risk devices and inspections conducted "for cause" are excluded from the program.
How can the MDSAP pilot program help medical device manufacturers?
Although regulators in countries participating in the MDSAP pilot program have placed some restrictions on their acceptance of audit reports, the pilot program still offers medical device manufacturers some opportunities to reduce the cost and time associated with pre- and post-market approval auditing requirements. More important, the MDSAP Regulatory Authority Council is likely to build on the successes and lessons from the pilot program to create a permanent single audit solution for medical device manufacturers. These and other actions promised a smoother compliance route for medical devices in the coming years.
TÜV SÜD is authorized to work with clients who would like to participate in MDSAP pilot program. If you are interested in participating in the pilot program, please visit TÜV SÜD America.
Gary Minks is the vice president of quality and regulatory affairs for TÜV SÜD America Inc., a Quality Digest content partner.
Comments
Cost saving?
Gary,
TGA accepts CE certificates or CMDCAS certs, or just about anything else.
Europe cannot require MDSAP, as they rely on multiple approaches to CE marking, not only QMS, and need all of the 67 Notified Bodies they are using to sustain their healthcare system. Sustaining the healthcare infrastructure must not be overlooked.
This is not a truly "single audit program" (one set of audit criteria). The IMDRF statement "Trade is not in our Terms of Reference", accurately reflects their regulators insistence on creating different, NATIONAL audit criteria, which is as follows:
Brazil GMP RDC 16/2013
USA FDA 21 CFR Part 820
Canada SOR 98/282
Japan MO 169
Australia - not really an issue, as they accept CE certs, ISO 13485 certs, if issued by CMDCAS or under the International Accreditation Forums, Multilaral Recognition Arrangement (currently only for IVDs).
Note that Brazil's new RDC 16/2013 was modeled after the FDA QSR structure. So it is very much out of alignment with MO 169 and ISO 13485:2003, CMDCAS and EN ISO 13485 used for CE marking.
All of them have their own national variations as well, so this is why the cost have been reported to be at least 25% higher than CE/CMDCAS ISO 13485 audits.
Why not a "single audit" (single set of criteria).
IMDRF could go further and write their own QMS. After all, isn't that what they all seem to be doing back at their offices? They have the expertise. I appreciate that regulators feel the need to be so involved with assuring that the auditors are qualified, but unless the MDSAP program is wrapped around a single set of audit criteria, it is more costly and burdensome than it should be.
In fact, it likely less to avoid it, except if your a large class III medical device maker selling to Brazil, and here's why...
The CE audit is accepted in Australia. Industry uses ISO 13485 as it is recognized in Australia and as its European cousin (EN ISO 13485:2012). ISO 13485 is also the main focus of the CMDCAS audit, which is what MO 169 is nearly identical to. So with the CE audit, you get Australia straight away, and Canada isn't a big leap in cost, and Japan's reg is also nearly identical.
Furthermore, the FDA QSR is free, and since it only occurs rarely, especially overseas, (where there is only 1 audit about every 20 years), MDSAP is particularly unnecessary for most manufacturers, especially low, to medium low device makers.
Brazil is probably the most troubling country to deal with, on many levels. Tariffs are really high to begin with, so many manufacturers are turned off by that. RDC 16/2013 is only enforced strictly on class 3 devices, and only about 7% of devices fall into that category, so 93% of devices would never be audit against it, so there is no cost issue there either. As RDC 16/2013 is aligned with the FDA QSR, so unless your making class III devices and selling into Brazil, the cost to benefit really aren't going to result in an advantage over sticking to the status quo.
Supporting something that is NOT designed to work right, from the get-go? This makes no sense. And then there is that sticky issue of having all the IMDRF members looking over the audit reports to see if they want to act on their own against the manufacturer. Do manufacturers want to risk getting an warning letter, if the MDSAP audit finds the manufacturer doesn't follow the FDA Quality System requirements well enough? This is also why FDA and Brazil should update their Quality System Regulations. They are out of alignment with ISO 13485 and the other regulated Quality Management SystemsAs ISO 13485 is nearly ready to be released in its newest glory, perhaps IMDRF members can make a knock off copy of the QMS, and start making a single set of audit criteria that is aligned with ISO 13485:2014. They are already knocking off some of the Accreditation standards requirement from the ISO 17021, so why not just go the rest of the way, and create their own IMDRF QMS? That is after all, what "Single Audit" was intended to mean.
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