117246, Russia, Moscow
Nauchny passage 17, entrance 2, floor 3, room No. 35

Registration of medical devices

for further circulation access on the territory of Russian Federation and EAEU countries
Since 2010,
we have been successfully registering medical devices (medical equipment, consumables, and in vitro equipment)

Our services

Our company is providing the following services
for issuing the registration certificate:
Customer consulting of documents content and preparation for registration of medical devices
Documents translations and notarization
Preliminary documents expertise, preparation and finalizing the registration application form with the Customer
Organization and support of toxicological trials, technical tests, clinical trials of medical devices, EMS tests, measuring equipment tests and verifications
Defining the risk class and type of the medical device based on medical devices classificatory
Registration dossier creation and submitting to Federal service of Healthcare (Roszdravnadzor)
Adjustment of documents (technical and operational documentation etc.) in compliance with current regulation of Russia and EAEU
Supporting of application on all the registration stages (local procedure, EAEU procedure)
Documents preparation for obtaining the samples import permit for medical devices for registration purposes
Registration certificate obtaining and transferring it to the Customer
As well, our company is ready to provide the following services:
  • Submission of changes to the registration certificate, registration dossier (VIRD, VIRU)
  • Obtaining Declaration of conformity
  • Obtaining the Regulatory certificate of conformity GOST R
  • Obtaining the Voluntary certificate of conformity GOST R
  • Obtaining the Manufacturing and technical maintenance license
  • Consulting on localization of production in Russia, as well as assistance in the localization process at existing manufacturing sites

Our advantages

We always offer optimal solutions for our customers
and stability
Our team professionals have an experience in registration more than 14 years
Support and
advisory services
We give the meaningful advice on any issues arising during the registration process
Time and
cost saving
We make an individual offer and describe all services included in the cost taking into account the time expenses of the process

Our clients


Submit an application