Preparing your organisation for MDSAP: Australia, Canada, Japan, Brazil
The International Medical Device Regulators Forum (IMDRF) established the Medical Device Single Audit Program (MDSAP) in order to develop a standard set of requirements for auditing organisations (Certification Bodies), for them to perform regulatory audits to the quality management systems of Medical Device manufacturers ruled by different authorities1. These requirements are not only valid to the regulatory authorities, but to third-party organisations that conduct such audits as well2.
The international members that are participating in the MDSAP include: the Australian Therapeutic Goods Administration (TGA); the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA ); Health Canada (HC); Japan Ministry of Health, Labor and Welfare (MHLW); and, the US Food and Drug Administration Center for Devices and Radiological Health (CDRH)2.
By following the MDSAP Audit Model, the participating regulatory jurisdictions hope that more consistency is achieved among the auditing organisations. As such, inspections performed for MDSAP are conducted in a consistent manner across auditing organisations; and, are performed in a logic and efficient way, with attention to interactions between processes. This way, auditors are allowed to be able to determine whether nonconformities of the systemic quality management systems (QMS) are present or not2.
The pilot program that ran until the end of 2016 by the FDA and its international partners, had very positive outcomes summarized in a “proof-of-concept” report published by the MDSAP Regulatory Authority Council (the international MDSAP governing body)3. The results of this report satisfactorily demonstrate the viability of the MDSAP. As such, the FDA has agreed to continue to accept MDSAP audit reports as a substitute for routine Agency inspections4.
Complying with the MDSAP standard is not easy, since it requires compiling years of QMS documentation and providing readiness throughout the three-year audit cycle. As such, in the “Stage 1 - Initial Certification Audit”, the MDSAP auditors thoroughly review the QMS to verify if products are safe, effective, and meeting performance standards. Then, in the “Stage 2 - Surveillance Audit”, the inspectors verify if the QMS continues to meet the required standards; however, this stage isn’t necessary if there have not been any significant changes since the last audit. Finally, in the “Stage 3 - Recertification Audit”, the goal is to evaluate the QMS once more, to confirm it is effectiveness and suitability according to all standards and regulations5.
It is expected that observers from FDA, Health Canada, or ANVISA can show up at the audit as part of the recognition process for the Auditing Organization (AO). Regulators need to observe three audits, plus one each following year to maintain the AO’s recognition6. As such, even though the regulator is in the room, it’s important that the company team focus on the actual auditor and not on the observer.
Also, it is likely that two auditors attend the MDSAP inspection in order to quickly cover more ground. As such, preparing to have two subject matter experts, two escorts, or even two conference rooms will make it easier when teams split up. Small manufactures that have personnel and space restrictions, should not despair and be prepared with documentation duplicates, so that all the information is quickly accessible to both auditors.
Despite the benefits, the other-side-of-the-coin is that the MDSAP does not excuse companies from audit processes attached to regions outside the participating countries. As such, medical device manufacturers who operate or distribute in other regions, must undergo the audit cycles required within those regulatory environments; which, for smaller manufacturers with fewer resources, could mean excessive costs to join the program5.
The need for quality of a bone screw should be obvious to everyone, and the same goes for any medical device7. Product recalls frequently make headlines and tarnish brand reputations as a result5. As such, medical device manufacturing requires the highest quality7. By ensuring that everyone in the organization makes quality an everyday priority, and set up a strategy for addressing QMS requirements according to MDSAP, will put any company in line with the guidelines and smooth the transition process.
As such, the companies should help their employees focus on creating quality processes and workflows that already adhere to the audit requirements. The MDSAP Audit Model comprehensive guide outlines everything organizations can expect from the audit, including all 90 questions they will be asked5. To ensure consistency, each audit is conducted in a defined sequence, where AOs will focus on evaluating seven different interrelated processes throughout the three-year, three-stage audit cycle:
Management;
Measurement, analysis, and improvement;
Design and development;
Production and service controls;
Purchasing; device marketing authorization;
Facility registration;
Medical device adverse events and advisory notice reporting
AOs leverage a grading matrix that divides the clauses of ISO 13485:2016 into two categories: those that directly and indirectly impact product safety and performance5.
The final non-conformities grade will be between one (least critical) and six (most critical), with any grade of five or above demanding an immediate intervention from the AOs and regulatory authorities5. Immediately and sporadically throughout the year, the manufacturer will go through AO check-ups, in order to guarantee their QMS issues are fixed.
An educational workshop to all company workers on the requirements and grading systems of the MDSAP, will ensure everyone is on the same page, and fully understands not only the initial, but also the continuing auditing process7. It is important to conduct gap assessments of all standard operating procedures (SOPs) and processes with an eye toward identifying risks; and, have internal subject matter experts that understand the ins and outs of the QMS and product lifecycle ready for any questions AOs might have5.
Being transparent, organized and prepared for the audits is of the outmost importance; and, there are tools that can help this task. An audit management software, for example, helps streamline audit tasks and centralize audit data, making it easier to maintain a strong record history and compliance7.
A highly customizable software solution to each manufacturer’s QMS processes and needs, and flexible enough to be scaled-up and support future growth, is a worthwhile investment. It can help configure customer forms and workflows that set up internal audits, automatically verifying individual standards, audit methods, and audit qualification. The system will also enable companies to flag potential risks along the way and keep an organized, traceable audit trail to quickly solve for risks5. By automating this process, there is an opportunity for medical device manufacturers to significantly reduce the waiting period for registering certain product types; improve staff efficiency by eliminating redundant, manual, and paper-intensive tasks; and create substantial cost savings along the way.
By allowing participants to provide feedback with a direct survey, the industry has demonstrated to be very welcoming and positive of the new program. The MDSAP audit is reported to be well planned and with well-organized expectations. It has an easy-to-follow set of guidelines provided in the MDSAP website, which allows companies to plan resources ahead of time. Also, MDSAP auditors are described to be experienced and well-trained, conducting audits in a reliably consistent manner4.
For example, ResMed Ltd., a leading medical device manufacturing company that develops innovative equipment to treat respiratory and breathing sleep-disorders8, has publicly endorsed the benefits of introducing MDSAP to the regular ISO13485 and EC certification company audits9. Because the company is able to know the scope of the MDSAP audit in advance, they state that it is easier to prepare and plan for the inspection, and to incorporate it into the regular in-company annual certification schedule. Also, if there are things that do not conform to the audit items, the MDSAP feedback is provided immediately to the manufacturer, making it easier to determine how to best deal with them. Not only that, but one audit-a-year saves time and personnel resources, bringing the costs of multinational companies down. Since, MDSAP is a task-based auditing method, by pre-establishing MDSAP’s requirements into the company’s QMS, ResMed has shown that it is possible to have a smooth and successful transition to this new audit program scheme9.
Canada has been a forthcoming MDSAP consortium member, and since January 1st 2019, that makes the program mandatory in order to legally sell class II, III and IV medical devices in its territory10. Since then, it has already received over 3000 submissions or MDSAP certificates, which represents over 90% of medical device manufactures11. In order to maintain Canadian market accessibility or apply to new medical device licenses, manufacturers must comply with the MDSAP certificate2. As we said above, the FDA will accept all MDSAP audit reports as a substitute for routine Agency inspections, minimizing manufacturing plant and personnel disruptions4.
The success stories of joining the MDSAP program have crossed its members boarders; and recently, Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT); and, the Republic of Korea’s Ministry of Food and Drug Safety have both joined has MDSAP affiliate members4. Also, the MDSAP was written into the United States-Mexico-Canada Agreement (USMCA) sectoral annex on medical devices, which means that Mexico may soon recognize it as well10.
ANMAT in Argentina and ANVISA in Brazil, have already exchanged medical device audit reports using the Regulatory Information Secure Exchange (RISE) module of MDSAP, that allows participating National Regulatory Authorities to benefit from a protected space to exchange non-public regulatory information12. Such exchange promotes reliance practices, improves processes efficiency, and expands regulatory convergence among members.
By integrating MDSAP tasks within an automated QMS, companies can go the extra mile and take advantage of the MDSAP certification. The program holds clear advantages for device manufacturers, and it will continue to gain momentum. As more countries recognize the MDSAP audit, the utility of the program will continue to increase.
Dr Catarina Carrao gained a PhD in Biochemistry fromNortheastern Ohio Medical and Pharmacy University and anM.Phil in Biochemistry at the University of Beira Interior. Shehas worked as a researcher at Max F. Perutz Laboratories,Yale Cardiovascular Center at Yale University School ofMedicine, and the Center Cardiovascular Research (CCR) at Charité Medical University.
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Parise T. Three Questions to Master Continual MDSAP Conformity. 2019;17th February 2020.
OrielSTAT_A_MATRIX. The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification. 2019;17th February 2020.
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ResMed. ResMed. 2020;17th February 2020.
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