Emerging markets present medical device manufacturers with a unique opportunity for growth. Many of these markets are focused on manufacturing as a way to drive economic growth. Increasing populations and healthcare reform are also driving demand for medical services and supplies. One such country with a rapidly expanding medical device market is Russia.
Medical device manufacturers and exporters need to be aware of regulatory changes in the Russian market, including the introduction of the EAC-mark and its related requirements. (All photos courtesy of Intertek)
Between 2012 and 2014, medical device imports from the United States to Russia were estimated to have doubled from $200 million to $400 million. There is room for additional growth in this market, as statistics show that the United States accounts for 20–25% of Russia’s medical device imports. According to various U.S. government reports, the most promising sectors include diagnostics, cardiovascular, ophthalmology, orthopedics and urology.1
While offering great opportunity for many manufacturers, Russia has its own regulatory system that must be considered. This system has undergone changes in recent months, meaning that medical device manufacturers and exporters need to be aware of multiple factors at play if they desire to enter this market. Beyond obtaining FDA approval and maintaining compliance to U.S. standards and certifications, there are several key considerations for trade in the emerging Russian market.
Russia, along with Belarus and Kazakhstan, founded the Eurasian Customs Union in 2010. It has since been incorporated into the Eurasian Economic Union (EEU) and expanded to include Armenia and Kyrgyzstan. The purpose of the Customs Union, and now the EEU, is to create economic efficiency and promote free trade of goods between its members. As a concept similar to European Economic Area, the Customs Union recently rolled out its own mark, similar to the CE mark, called the EAC mark, which went into effect in March of this year.
The EAC mark may present some challenges for manufacturers interested in entering Russia, as it is likely they have been using the GOST standards, put in place by the Soviet Union and continued in use by the Commonwealth of Independent States. However, GOST is being replaced by EAC in most cases, so it is important to understand the process for registration and certification to EAC when entering the Russian market.
In Russia medical device registration must be completed prior to any certifications, such as EAC marking. Registration is completed through Roszdravnadzor, Russia’s equivalent to the FDA. Also referred to as the Federal Service (FS), this department of the country’s Ministry of Health requires a manufacturer to prepare a dossier for imported medical devices using FDA files. This registration covers safety requirements for the device.
If applicable, radio and electromagnetic compatibility (EMC) requirements may also apply. Radio requirements for Russia include RF certification from the Federal Agency of Communications (FAC) and Federal Security Service (FSS) notification, if the device uses encryption. EMC requirements include review by Roszdravnadzor/Ministry of Health/FS, radio certification (if applicable) and compliance with the old GOST-R standard. Some agents also require a CU EAC Declaration of Conformity (DoC) for customs clearance. As such, it is highly recommended that a medical device receive both a GOST-R DoC and a CU EAC DoC.
Under the new EAC-mark requirements in Russia, EMC testing—conducted in chambers like the one seen here—may be required of devices it order to illustrate compliance with the previous GOST-R standard, which remains unchanged under the new mark’s standard.
In addition to a dossier, manufacturers are also required to compile a risk management file (RMF). The RMF should contain context around the risk management process as well as information on identified risks for a product. In addition to identifying the risks, each must be fully assessed, and guidelines and recommendations for mitigating risks should be outlined. Manufacturers must also be able to illustrate a monitoring system is in place to ensure continued assessment and mitigation.
To ensure technical accuracy, the RMF and dossier will need to be translated in Russian by a “responsible body”. Responsible bodies are accredited by Russia’s Federal Service for Accreditation (ROSACCREDITACIA). The paperwork, along with information related to factory inspections for any facilities in the country conducted in line with ISO 13485 or ISO 9001, will be submitted to the Ministry of Health, where it will reviewed in a manner similar to the USA 510(k) review process. Samples may be required at the discretion of the Ministry.
Once an application is approved, the device is reviewed for clinical evaluations. Based on similar products already on the market, evaluations target the best doctors and hospitals. All clinical trial data must be submitted before a product can be fully approved by the government. It may take anywhere from eight months (if similar products are on the market) to a year or more for new products to the market.
During the review period, the certification body has two objectives: 1) to find faults and errors in the documentation and applications and 2) to certify the equipment for use. To that end, manufacturers must be prepared to make corrections to all documentation and the application. Forms or regulations may change, making corrections necessary. Photos and other data may be required to supplement the corrections. It is also important to be prepared for incomplete or erroneous clinical trial data and have a plan to address such issues, should they arise. If any such issues do occur, it will be necessary to resubmit documentation and applications, including fees.
These considerations, coupled with the changes underway in Russia, make entering the market seem both desirable and daunting for many medical device manufacturers. The following are some best practices that manufacturers can employ to better navigate these changing waters and help ensure success.
Increasing populations and healthcare reform are driving demand for medical services and supplies in Russia.Get familiar with the EAC Mark and its related requirements. In Russia, the certification needs for this mark are similar to those of GOST; however, it is important to understand the differences, as the EAC Mark is replacing GOST. Additionally, it is also key to be aware of the differing requirements between Russia and the other members of the Customs Union. In short, certification in Russia will entail utilizing the EAC Mark and its criteria, while also meeting Russia’s specific standards and legal requirements.
Identify local representation. Like many markets, Russia requires in-country representation of any manufacturer looking to bring products into the country. This could include: a company-owned manufacturing or sale site within a country’s borders, a distributor operating in a country, or an in-country paper holding agency. Additionally, be prepared to confirm that any local suppliers and/or distributors meet inspection requirements and know how to coordinate any follow-up inspections, should the need arise.
Prepare your documentation. This includes your application, dossier, labeling, clinical trial test results, user manual and FDA filings. All paperwork must be translated by an organization approved by the Russian government, so it will be important to do the legwork to identify an approved translation resource.
Test your device. Depending on the device, this may include EMC evaluations and radio frequency, in addition to testing/certification to EAC mark standards. Consider using a third-party to conduct testing in line with Russia’s requirements.
Prepare for clinical trials. This may take up to a year, and follow-up trials may be needed if there are any issues with the data being collected or if Roszdravnadzor requires additional information or data.
Entering the Russian market presents many opportunities and challenges for medical device manufacturers. New regulations and the introduction of the EAC mark, mean a new process and certification considerations for the region. However, the reward of entering a market poised for growth may outweigh the risks.
Tony Blank is president of Infinity Biomedical Group. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Immediately prior to forming Barton & Blank, Blank spent 12 years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups—including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Blank has worked with cardiopulmonary, surgical, ophthalmic, vascular access and critical care medical devices.
Pat Baird works at Philips as the head of global software standards. Baird likes to think of his job as “policy engineering”— understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers and training to meet those needs. Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the director of risk management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented more than 50 papers regarding product development. Baird has an MBA and a Masters in healthcare quality and patient safety from Northwestern University.
Roberta Goode, Principal Trainer, Altrec
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created more than 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for the world’s largest medical device manufacturers, Goode turned her attention to sharing that wealth of accumulated knowledge. Look for her in 2018 in a technical training and mentoring role as the head of Altrec, LLC.
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Susan Alpert, M.D. is president of SFA Consulting, LLC. She previously served as senior vice president, chief regulatory officer at Medtronic and was responsible for all of the company’s global regulatory efforts. Prior to joining Medtronic, Alpert served as vice president of regulatory sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation.
Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. She serves on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products.
Dr. Christopher Joseph Devine is the president of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).
Mark Leimbeck is the principal of UL Solutions Risk Management Practice. He has served as a subject matter expert and advisor in a number of functional areas, including risk management, quality management, project management, software application development, and engineering. During his career, Leimbeck has led and supported the implementation of various corporate improvement and development programs including quality system and regulatory compliance programs, new product development, IT systems and enterprise resource planning (ERP) implementation, and quality/lean Six Sigma process improvement projects. Leimbeck continues in a subject matter and advisory role, and participates in international, national and industry-based standards and guidance development committees. He holds a B.S. E.E.T. from Southern Illinois University and an M.B.A from the University of Chicago.
Stephen Wilcox, Ph.D., FIDSA is a principal and the founder of Design Science (Philadelphia), a 30+ person firm that specializes in optimizing the usability of products, particularly medical devices for clients including many major multinational corporations. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He also served for several years as Chair of the IDSA Human Factors Professional Interest Section.
Wilcox also serves on the Advisory Boards of the Industrial Design Department of Philadelphia University and the School of Design of Carnegie Mellon University, on the Human Factors Engineering Committee of AAMI, and on the ISO/IEC committee (“Working Group 4”) that wrote the standard, IEC/ISO 62366. He holds a BS in psychology and anthropology from Tulane University, a Ph.D. in experimental psychology from Penn State, and a Certificate in Business Administration from the Wharton School of the University of Pennsylvania. He has won a number of design awards, has guest edited the journal Innovation several times and has served as a judge for a number of product design award competitions.
Wilcox has given hundreds of invited addresses to various organizations, has published more than 70 articles in professional journals, and is the current Editor in Chief of the Human Factors and Ergonomics Society journal, Ergonomics in Design. His book, Designing Usability into Medical Products (CRC/Taylor & Francis), co-authored with Michael Wiklund, was published in 2005.
Alberto Velez is a consultant for Chimera Consulting North America, LLC. Velez is a recognized expert in organization development for combination products with more than 12 years of experience in applying CGMP concepts to more than 35 combination products in new product development, manufacturing and quality systems. He is a frequent speaker on combination products topics at industry meetings and has more than 30 years of varied experience in medical device and combination product quality assurance, FDA readiness, product development and organizational effectiveness in the pharmaceutical and medical device industries. Velez has applied the CGMP’s/QSR’s to several different divisions in the Johnson & Johnson family of companies as well as other smaller medical device companies. He has also led R&D teams to develop and launch new technologies in endoscopic surgery and enteral feeding. His educational background is in chemical engineering, industrial engineering and quality engineering.
John Pracyk, is a rare Neurological Surgeon with an uncommon blend of business and medical expertise. This sophisticated futurist is recognized as a national thought leader in the design, development, and management of collaborative care delivery based on his history of healthcare program build-outs and medical administration successes. An accomplished writer and platform speaker, he is a frequently requested keynote speaker at prestigious organizations such as the Congress of Neurological Surgeons, The Barrow Neurological Institute, and Stryker Performance Solutions.
Having completed a healthcare-focused MBA from the nation’s preeminent physician-only degree program, with a Master’s thesis on competitive strategy and service-line development, Dr. Pracyk is a proactive innovator who inspires teams to surpass organizational goals, exceed patient care metrics, and enable transformational change. Healthgrades acknowledged him with their honor roll distinction.
His career to date has been characterized by three key elements: First, his ability to foster multidisciplinary consensus and collaborative care; second, his grasp of competitive strategy as a program architect; and third, his ethics-driven approach to medicine. While recognizing that revenue generation drives business, Dr. Pracyk balances business necessities with patient care and market realities. In 2016, Johnson & Johnson Medical Devices appointed him Franchise (Worldwide) Medical Director for Spine.
Patrick Caines is director, quality & post-market surveillance at Baxter Healthcare where he is responsible for the company’s global post-market surveillance and associated quality systems. Caines has 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.
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