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Registration of medical device | in the EAEU
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Olga Soldatenkova | Director of Expert Work
Comprehensive problem solving

We approach any problem of registration of medical devices comprehensively. Any project in RegTrend begins with a detailed analysis of the project, so before we start working, you will receive a full picture of your case, comprehensive information about the risks and all options for implementing your project.

FlexibilitySafetyReliabilityService
If your project can be implemented in different ways, you will always receive a full list of options and our recommendations that will allow you to complete the work optimally in terms of time and cost.
All information on each project is confidential, and to avoid any doubts, we sign an NDA.
Each employee of the RegTrend expert department has more than 10 years of experience in the registration of medical devices. During this time, they have received over 150 registration certificates.
Each RegTrend employee knows how to provide you with comfortable cooperation and clear control over your project. We are already creating a convenient service and information environment, so stay tuned for updates.
Initial assessment
Documents
Accompaniment
For each project, we select the most suitable registration option based on its specifics, and provide recommendations for project implementation in order to reduce the time required to register a medical device.
80%
We undertake the development of turnkey documents: we do 80% ourselves, and for the remaining 20% ​​we collect and consolidate into a set of registration dossier.
We assist in testing, organize sample delivery. We find optimal contractors for translation of source documents (for foreign manufacturers), their apostille and delivery. We submit documents to the RZN and receive a registration certificate.
20%
Это документы и информация, которые необходимо предоставить клиенту
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We will register your medical device

Our experience in the field of registration, accumulated over more than 10 years, as well as experience in communicating with Roszdravnadzor and its subordinate expert organizations, allows us to “understand” the requests and requirements of state expertise, which allows us to save our clients time when reviewing documents for a medical product in a government agency. Partnerships with accredited laboratories allow us to organize and conduct tests in full compliance with registration rules and in the shortest possible time.

Just leave a request in the form and we will contact you!

О компании
Alla Sharonova | Operations Director
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Individual approach

We create individual terms of cooperation for each client.
We take into account all the features of your product.
We flexibly adapt to the format of work convenient for you.
We will always offer all available options for registering your product.

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