August 18, 2011
Russian market was about $3.3 bln. in 2009, fall into TOP-20 global markets. Expected annual market growth is about 5.4-11%. At the same time around 75% of medical device market is supplied by import. With expanding funding for health care, implementation of national program for health care modernization and highly decentralized decision-making procedures Russian market becomes one the most attractive among emerging markets. However regulatory system is Russia is complex, non-transparent and inconsistent. Also, it is essential for building effective market access strategy to understand cultural and common business environment in Russia. Synergus, leading medical device consulting company will help your business discover excellent opportunities in the fast-growing, but challenging Russian market.
OUR SERVICES
REGULATORY AFFAIRS IN RUSSIA
• Product registration – full process (product documentation for registration submission to Federal Service for
Surveillance in Health Care and Social Development (Roszdravndazor), translation of registration dossier, identification of registration agents, distributor, establishing product standard, application for sample-product import permission for registration test, coordination of obtaining GOST R Certificate in Federal Agency for Technical Regulation and Metrology (former Gosstandard), coordination of all related activities)
• Translation of technical documents into Russian
• Courses on Russian regulations of medical devices and IVD devices
• Coordination between you and your partner in Russia
REIMBURSEMENT AND PRICING SERVICES IN RUSSIA
Reimbursement and Pricing
• Market access strategy, identification of the relevant reimbursement pathway
• Strategy to optimize or change reimbursement
• Mapping of stakeholders, decision-makers, opinion leaders
• Pricing evaluation and strategy
• Market prioritization
• KOLs expertise analysis on target area
Health Economics and Value Communication
• Evidence development strategy
• Systematic and literature reviews
• Health economic modeling
• Budget impact analysis
• Real world data on treatment and diagnosis patterns
Hands-on Execution Support
• Approaching funding authorities (Ministry of Health and Social Development, regional Ministries of Health, health
services of parallel and private health care systems)
• Support in dialogue with hospitals and other stakeholders
• Support in communication with local distribution companies