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Application for medical device development service

Application for Medical Device QMS Service

Application for medical device registration service

Application for registration of medicines

Request for service of amendments to RC/RD

Request for marketing research service for MD and Pharmaceuticals

Application for technical and medical translation

Localization of medical products production in the territory of the Russian Federation allows:

The process of transferring part or all of the production cycle of medical equipment and products to the territory of the Russian Federation requires careful preparation
and support at all stages. Therefore, it is recommended to involve experienced specialists and consultants in its implementation.

Our company offers services for supporting the localization of medical device manufacturing, from concept and business plan development to production launch and post-market support.

способствует созданию новых рабочих мест

contributes to the improvement of product quality by controlling all production stages

provides access to government support programs in the form of benefits and subsidies

reduce import dependency

The range of services can vary depending on the specific project and customer needs.

During this phase, experts of the RZN_Expert will assess the volume and trends in the development of the Russian market for medical products. Identify key market players, assess their market share, analyze product range, price policy. Make a comparative analysis of imported and domestic analogues.

Market and competition analysis

01

Analysis of Russian enterprises with experience in the production of medical products or related products. Development of documents for the conclusion of cooperation agreements.

Find partners and suppliers

03

Preparation of a package of documents for registration of medical device and receipt of authorization documentation. Organization of medical products testing for compliance with technical regulations. Submission of documents to the Russian Surveillance Agency for obtaining a registration certificate.

Registration and certification

04

Introduction of changes in technological processes taking into account the characteristics of Russian production. Technical documentation transfer: drawings, process maps, specifications and other technical documentation. Training of Russian specialists in technological processes of production, quality control and operation of equipment.

Transfer of technologies

05

Assistance in preparation of production sites, installation of equipment. Testing of test batches to confirm compliance with requirements. Launching of medical products series production. Logistics chain management.

Start of production

06

Development of marketing strategy for product promotion in the Russian market. Construction of distribution network to ensure the sale of products. Presentation of products at specialized events, participation in exhibitions and conferences.

Marketing and sales

07

Collecting information about product quality. Monitoring of market changes, adapting products to new requirements. Assistance in the introduction of new technologies and improvement of production efficiency.

Post-marketing monitoring

08