The Russian Medical Device Market: it is System not Tools that should Alter
The non-compliance with international practices of standards currently acting in Russia for medical device production and of rules for their circulation is a serious barrier on the Russian medical industry’s way into the global market. This problem was unanimously stated by both businesses and market regulators during the SGS Forum “Managing Quality and Safety of Medical Devices in Global Markets”, which took place on April 21, 2011 in Moscow. The event was organized by the SGS Group, the world leader in inspection, verification, testing and certification services. The forum gathered over 70 professionals from the industry. Both local and international manufacturers of medical devices participated to the discussion.
Chris Jepson, SGS Global Manager for Medical Devices and Chairman of NB-MED, noted that today all major regulators in the international medical device market are focused on active interaction and harmonization of legal framework. For Russia, development of a single approach to conformity assessment within the framework of the Belarus-Kazakhstan-Russia Customs Union and development of the Customs Union Technical Regulation On Medical Device Safety is the first step in this direction. According to Oksana Kurochkina, Member of the Expert Council at the Secretariat of the Customs Union and Deputy Head of Customs Advocate Collegium, one of the main tasks of the Customs Union is to provide for a coordinated policy in the field of technical regulation and sanitary measures.
However, while the progress of the reform of the technical regulation system for medical devices has been vague so far, Russian companies do not stand still and have been implementing international standards bringing their products in compliance with global market requirements. Particular attention of the forum’s delegates was attracted by the presentations of Elena Grebenschikova, Head of Certification in NIPK Elektron, and Yakov Grinberg, General Director of OKB Ritm, who shared their case studies on promotion of medical devices to EC, USA, Canada, South Korea, Australia, China and other countries. This is international certification that allowed Russian manufacturers to be equal in rights with global medical device competitors and to pursue adequate pricing policy. In addition, as shown by practical experience, the availability of international certificates also boosts competitiveness in the local market.
The list of advantages of complying with international standards was completed by Alexandra Tretyakova, Executive Director of IMEDA (International Medical Device Manufacturers Association), who draw the attention of delegates to the problem of the war for talent. The modern organization must take care of its image not only in the eyes of customers, but also in the eyes of its employees, since adherence to quality is one of employer’s evaluation criteria. And, qualified personnel is one of the key success factors in the global market. Moreover, Good Manufacturing Practice features qualified personnel and continuous education as the key tool to achieve product safety, reminded Alexander Popov, SGS Senior GMP Auditor in Eastern Europe and Middle East.
Alexandra Tretyakova noted that the industry is characterized by dynamism, global competition, large nomenclature and global shift to personalization and individualization of medical devices. Beside qualified personnel, other success factors are flexibility and speed of interaction with other industries as well as response to the needs of users and other stakeholders. Alexandra also emphasized that compliance with quality standards is not a competitive advantage but a pre-requisite for operations in a global market. The main task is to provide for accessibility of optimal medical technologies to all patients taking into account regional specifics, opportunities and needs.
More than once the lack of systematic approach towards quality management in Russian companies was raised within the forum’s discussion. In the opinion of Andrey Ivanov, Project Manager for European Certification at SGS Vostok Limited, this is the major issue when domestic manufacturers implement ISO 13485, the standard that lays the basis for medical device regulations in EC, Canada, Australia, China, USA, Japan. Harmonization of the Customs Union Technical Regulation long-awaited by all industry players with European Directives, which was mentioned by Yuri Larionov, General Director of VNIIIMT of Roszdravnadzor, should help to fill in this gap. However, as emphasized by Andrey Vilenskiy, the General Director of Meditex, borrowing separate elements/tools from international regulatory environment would not bring the expected effect if we do not adopt the whole system where those tools can operate.
Tatiana Apatovskaya, Marketing Manager for Russia, SGS
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