GxP Lifeline
"The Medical Device Single Audit Program: Accessing International Markets, Part 1"
EDITOR'S NOTE: This is the first of a three part series on MDSAP. Read Part 2 here and Part 3 here. The medical device market is no stranger to wide-ranging regulatory changes, from the new version of ISO 13485 to the European Union's Medical Device Regulation (MDR) to the international Medical Device Single Audit Program (MDSAP). This is part one of a trilogy of articles aimed at showing you the ins and outs of implementing the MDSAP.
The MDSAP is an international regulatory program designed to smooth out the process of selling medical devices in Australia, Brazil, Canada, Japan and the United States. It involves a single quality management system (QMS) audit for medical device manufacturers for a standardized validity and acceptance in all five countries.
Member countries of the program along with their regulatory authorities and regulations include Australia, Brazil, Canada, Japan and the U.S. Organizations with observer status are the European Union and the World Health Organization.
The Question of Market Access
As you will have realized, the MDSAP is part of a general shift in global regulatory compliance and has become an essential point of consideration for any medical device company drawing up a strategy for entering international markets. This is especially true for the Canadian market. Since 2014, Health Canada has entered a transition phase as it moves from the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program to the MDSAP. During the transition, certificates from either program are valid, but beginning Jan. 1, 2019, only the ISO 13485:2016 compliance certificate within the MDSAP framework will be accepted for manufacturers wishing to market Class II, III and IV medical devices in Canada.
Goals of the MDSAP
- Simplify regulatory monitoring of manufacturers' QMS to allow them to meet the needs of multiple regulatory areas without any extra work.
- Authorize a single regulatory check to optimize the use of time and resources in assessing manufacturers' compliance and make the whole process easier.
- Foster closer alignment of global regulatory approaches and technical requirements without infringing on the sovereignty of individual authorities.
- Promote consistent, predictable and transparent programs by streamlining the procedures and practices of regulatory bodies.
How Will MDSAP Impact Medical Device Manufacturers
By combining several regulatory audits into just one process, the MDSAP could save time, effort and money for medical device manufacturers. Instead of preparing for audits from five different regulatory bodies in a year, the manufacturer only needs to undergo one audit to meet the requirements of all five.
Although the MDSAP simplifies the audit process to an extent by combining several audits into one, the audit is still a complex operational undertaking. Its scope doesn’t only encompass the QMS requirements in ISO 13485:2016, Brazilian good manufacturing practices, and the FDA quality system regulation (CFR Title 21 Part 820). It also covers other important requirements from regulatory bodies, such as registration, issue of licenses and reporting of adverse events. An MDSAP audit is therefore likely to be more drawn out than a traditional audit by a single regulatory body, with auditors typically spending a week or more on-site rather than a few days.
Do you need guidance in meeting regulatory requirements? Contact us at www.apsalys.com.
Jean-Christophe Gourmanel is a business development engineer with over 20 years of experience in the pharmaceutical industry including working for one of the five largest pharmaceutical companies. He has held technical and management positions, acquiring solid experience in project management, sales processes, communications, quality management, and quality systems. Gourmanel developed and implemented a complete Six Sigma process at Janssen Cilag. In 2008, he founded and was CEO of a company that specialized in web technology business solutions for life science companies. Gourmanel then served at Straumann, a leading international dental implant company for six years as head of France key accounts, where he was involved with international topics, including Good Manufacturing Practice (GMP). He works currently as a sales manager and implementation project manager for MasterControl’s French partner Apsalys in life sciences strategic consulting and technical implementation solutions for French-speaking countries. Gourmanel is also a fan of scuba diving and spends his spare time in the beautiful area of Arcachon. He can be contacted at jc.gourmanel@apsalys.com
Tifany Desprez has joined Apsalys as its communication and marketing manager. She graduated in 2015 with a doctorate degree in neurosciences from the University of Bordeaux in France and worked as an assistant in communication at Bordeaux Neurocampus. Desprez continues to develop her interest in scientific innovation and information exchange in business access to life science organizations. She enjoys connecting with other life science industry professionals to gain insights about compliance and quality challenges. Desprez can be contacted at t.desprez@apsalys.com.
