We bring medical brands to the markets of Russia and the EAEU on a turnkey basis
of medical brands was successfully
launched on the Russian market
Support for registration of medical products — from the formation of the registration dossier to obtaining the registration certificate.
Term: from 6 months.
Support for making changes to the medical product registration dossier — from organizing tests and studies to obtaining an updated registration certificate.
Term: from 1 month.
Development of technical and operational documentation for a medical product (technical specifications, extract from the technical file, operational documentation, etc.).
Term: from 1 month.
Organization of technical, toxicological, and clinical trials, interaction with testing centers and laboratories, adjustment of dossier documents, preparation of the program, protocol, and evaluation report based on the test results.
Term: from 2 months.
Production inspection is an assessment of manufacturing compliance with the requirements for the implementation, maintenance, and evaluation of a product quality management system, depending on the potential risk of its application.
Production inspection is mandatory for medical devices of classes 2a (sterile), 2b, and 3. Inspections apply to both domestic and foreign manufacturers.
An inspection report is required for the state registration of medical devices and for making changes to the registration dossier.
The inspection is conducted by Roszdravnadzor and its subordinate institutions.
We provide support for initial, scheduled (periodic), and unscheduled inspections.
Term: from 2 months.
Clinical safety monitoring, promotion, distribution, and more — obtaining permission for sample import, post-registration monitoring, corrective action programs, support during regulatory inspections, market potential assessment and feasibility of product launch, development of a product promotion concept and market entry support, information campaign for a new product, business strategy development, and distribution.
Term: from 3 months.
Process organization is our responsibility.
You will receive complete documentation ready for use.
We apply all available legal mechanisms to achieve the result.
is one of the oldest law firms specializing in the implementation of healthcare projects
successfully introduced medical brands to the Russian market
years of experience in the registration of medical devices
our team: lawyers, economists, doctors, marketers, sociologists, and others
legal support for tasks of any complexity in the field of medical device regulation
pharmaceutical companies, medical device manufacturers, distributors, healthcare organizations, and other companies implementing healthcare projects
We completed the registration of the medical device faster than expected — the full cycle of support really paid off!
The tests were carried out without delays, and competent support eliminated the risk of registration refusal!
We promptly made changes to the dossier and eliminated bureaucratic complexities — let’s keep moving forward!
Here you will find answers to the most popular questions. If you didn’t find the information you need, feel free to contact us!
The registration time depends on many factors, including the client’s readiness to submit the documents. On average, the process takes from 6 months to 1 year. If testing and research are required, the timeframe may be extended.
Yes, we provide services for supporting the changes to the registration dossier.
EAEU registration requirements differ from those of other countries. Additionally, research, testing, and inspection results must be provided. Beyond translating the documentation, it will likely need to be adapted to comply with local legal requirements. Our lawyers will assess the content and inform you of any additional information that needs to be provided.
