Support of medical devices production localization in Russia and Eurasian Economic Union (EAEU)

We offer our foreign partners a full range of services on informational, analytical, organizational and technical support of projects on localization of medical devices production. Service is particularly relevant in connection with the adoption of Government Resolution No. 102 of February 05, 2015 "Establishing Market Entry Restrictions for Individual Types of Medical Devices Originating from Foreign Countries in the Context of Procurement for State and Municipal Needs".

Our services for medical devices production localization include:

Marketing research. Identifies potential competitors and perspective niches in the Russian market.
Analysis of legal and regulatory-technical framework, including analysis of legislation, standards, conducting patent research (including research on patent clearance). Allows you to determine rationale of own manufacturing and to assess all possible risks to business prospects.
Feasibility study and business plan preparation and defense. Required by Russian and foreign financial institutions.
Development / modification of specifications, manual (instruction for use), design / technical / operational documentation. Required for technical purposes and for the use of Government Resolution No. 102 of February 05, 2015 "Establishing Market Entry Restrictions for Individual Types of Medical Devices Originating from Foreign Countries in the Context of Procurement for State and Municipal Needs".
Medical devices state registration support. The service is in-demand by business because of the more complex procedures since 2013.
Implementation of ISO 13485 quality management system and ISO 14971 risk management. Preparation for certification.
Preparation of documentation and support of expertise of the CCI of Russia on determining the country of origin. Required for the use of Government Resolution No. 102 of February 05, 2015 "Establishing Market Entry Restrictions for Individual Types of Medical Devices Originating from Foreign Countries in the Context of Procurement for State and Municipal Needs".
Development of the optimal production localization scenario in Russia and EAEU. The use of methods of economic-mathematical modeling allows to choose the most suitable option of production localization given the potential risks.
Full informational, analytical, organizational, and technical support of the project. Providing your company highly qualified specialist on the outsource basis throughout the whole project.
Market Access (considering current market position). Development and organization of measures system on products promotion in the Russian market, including increased brand awareness and customer loyalty. These activities increase the share of the producer in the segment and reduce the payback period of the project.

Turning to professional consultants, you minimize costs, save time and get the comprehensive services of the highest quality.