2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)
March 2, 2017 Marci Crane, Staff Writer, MasterControl
For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of multiple regulatory jurisdictions.”(2)
Why Participate in the MDSAP?
It’s a rare occurrence today to sell medical device products in only one country or within the purview of only one set of regulations related to the quality management of that product. When the decision to sell on an international scale is made, there are more regulations to which medical device manufacturers must comply. But what is the MDSAP and how can it help?
The MDSAP is designed to allow approved auditing organizations (AOs) to audit medical device manufacturers’ processes and products against one comprehensive set of standards. These standards are mostly based on the 2003 version of the ISO 13485 standard but also include all necessary addendums and clauses from regulations specific to the various geographies participating in the program.(3) These geographies, as mentioned above, include Australia, Brazil, Canada, Japan and the U.S. Put simply, medical device manufacturers can now be audited one time per year and upon successful completion of the audit, will be allowed to sell products in all countries participating in MDSAP.
Reducing Regulatory Burden within the Medical Device Industry
Medical device companies consistently seek to decrease regulatory burden. All of the various regulations related to the production and distribution of medical devices and originally stipulated by MDSAP participating countries and their respective regulatory bodies are valuable. However, there is considerable overlap between these regulations and it’s unnecessary to audit the same processes multiple times to determine compliance with benchmark quality standards. In the end, more audits, more approvals, more certifications, more checks and balances, all represent more time.
Why More Audits Result in Delayed Product and Why Delayed Product Is Important
Every business with a product to sell knows that time-to-market is an important factor to be considered in all product-related decisions. However, for a medical device company the time-to-market factor is especially pertinent as 1) speed-to-market generally contributes to the health or overall life-support of a customer and 2) the research, development, design, production and quality inherently required throughout the “birth process” of a medical device are expensive and require the fastest ROI possible to keep the company in good financial health. However, despite this “need for speed” quality can never be compromised within the medical device manufacturing environment. A necessary improvement in speed and quality is where the MDSAP can help. With only one audit required annually, the MDSAP will save medical device manufacturers significant time that can be used toward getting quality products to market at an improved rate.
The Recent History: IMDRF Brings International Medical Device Regulators Together
A new task force was created in October of 2011. This task force, which consists of a group of medical device regulators from the countries mentioned previously in this article, as well as official regulatory observers from the EU and the World Health Organization (WHO), is the International Medical Device Regulators Forum (IMDRF). Much like the Global Harmonization Task Force (GHTF), the IMDRF has as its mission the acceleration of regulatory harmonization and convergence. Unlike the GHTF, however, the IMDRF focuses solely on the medical device industry and its unique regulatory needs.
The IMDRF is officially represented by the following regulatory bodies:
- Australia’s Therapeutics Goods Administration (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Canada’s Health Canada
- Japan’s Ministry of Health and Labour and Welfare (MHLW)
- The EU (official observer)
- WHO (official observers)
Additional Goals of the IMDRF
There are many benefits to the harmonization of any group of distinct---yet similar---regulatory or quality requirements and the IMDRF seeks to create that harmonization for the benefit of the professional medical device community.
Additional goals of the IMDRF include:
- Improved medical device safety without compromising rates or production
- Product manufacturing improvement on an international scale (global alignment in the medical device community)
- Improved oversight of medical device quality management systems
- Minimal regulatory burden on medical device manufacturers
- Improved efficiency in the process of identifying errors, critical issues and product damage
- More productive use of manufacturing and regulatory resources
More on ISO 13485:2003 and the Newly Revised ISO 13485:2016 Standard
Though the MDSAP was primarily designed to audit against standard
s based on ISO 13485:2003, updates will need to be made as new revisions of the ISO standard emerge. Such was the case last year when the latest revision of the ISO standards (ISO 13485:2016) became official. The IMDRF will continue to update the MDSAP based on future revisions of ISO 13485 standards and the regional regulations of its contributing regulatory bodies.
The MDSAP Pilot
The pilot for the MDSAP was held from January 2014 until the last day of 2016. January 1, 2017 marks the full implementation of the program.
Regarding the MDSAP pilot, the FDA reports the following:
“The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient effective, and sustainable single audit program focused on the oversight of medical device manufacturers.””(2)
What Are the Benefits of Participation in the MDSAP?
The main benefit of participating as a medical device manufacturer in the MDSAP is a reduced regulatory burden. What does this mean? Primarily it means that a single audit can be conducted in lieu of multiple audits or inspections performed by various regulatory authorities or representatives. The U.S. FDA’s MDSAP FAQs page also mentions the following benefits of participation in the program:
“…it is expected that the program will enhance confidence in the reliability of third-party audits, that more Regulatory Authorities will join the program, and that other Regulatory Authorities will use information made available through the program to limit the need for additional audits.
“Some participating regulatory authorities will use MDSAP…audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.”
“Like in any third-party auditing program, the medical device manufacturer is free to choose among all authorized auditing organizations to perform the audits. Routine audits are announced and planned with the manufacturer.”
“The MDSAP…is expected to improve the predictability of audit outcomes through enhanced auditing organization recognition criteria, monitoring of auditing organizations by the participating Regulatory Authorities, the use of a standard MDSAP audit model, the grading of any nonconformity using objective criteria to characterize the significance of the finding, the reporting of the audit outcomes using a standard report template.”
2017 is the Year to Consider Participation with the MDSAP
The MDSAP is now a live program for all medical device manufacturers seeking to sell products within the regions of the participating geographies. Any medical device manufacturer selling medical devices in one or more of these countries can now audit against the regulatory requirements of all of these countries only one time each year!
According to MDSAP staff fellow Marc-Henri Winter, “Any manufacturer of medical device distributing their medical devices in these countries – regardless of their geographic location---should consider participating in the program.”
Participation in the program, as specified numerous times in this article, includes multiple benefits and doesn’t compromise the necessity of producing a quality product.
Can “Outside” Countries Participate in the MDSAP?
The answer is yes. Also according to Winter, “Europe has been an official observer since the beginning of the MDSAP Pilot. They have observed some assessment activities and will do a few more before they can make a decision on whether and how outcomes of MDSAP audits could be used in the European context.”
Winter also adds that “There is no plan at this time for having more countries join the consortium of participating regulatory authorities. However, other countries are welcome to use MDSAP certification documents as evidence of the manufacturer’s appropriate quality management system.”(4)
The benefits of auditing once per year to determine the safety and saleability of a medical device product are numerous. Medical device companies will save valuable time when delivering products to market with increased efficiency, and will spend less time communicating with various notified bodies and authorized auditors from across the globe.
How Are MDSAP Auditing Organizations Recognized by the MDSAP Program?
Those organizations that seek to become MDSAP auditing organizations (AOs) must submit an application to the MDSAP. Organizations that have submitted an application, as well as their approval status, are shown on the MDSAP’s AO organization availability chart with their respective approval and recognition status.
Medical Device Improvement
At the end of the day, week, month or year the real essence of creating products is to change people’s lives for the better. There is generally room to grow and improve and the MDSAP takes a step toward greater medical device efficiency and quality across the globe.
1. As of 2017, medical device manufacturers who plan to sell product only in Canada will be required to adhere to replace the CDMCAS QMS certificate with the MDSAP certificate. (http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap-trans-notice-avis-eng.php)
2. Though the MDSAP pilot is complete as of December 31st of last year, 2017 marks the official “go live” for the program.
3. It is important to note that the standards against which approved MDSAP AOs perform audits have now been updated to the ISO 13485:2016 standard.
4. Winter also remarks regarding Canada, “Those manufacturers who distribute their medical devices in Canada will have to participate in the program in order to maintain the validity of their device licenses beyond Jan. 1, 2019, at which point MDSAP will replace CMDCAS.”
5. “Audits will be conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP.” (http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf)
Marci Crane is MasterControl’s localization manager and a marketing communications specialist. Marci has written on topics relevant to the life science industries for more than 10 years.