07 января 2020

The list of software registered as a medical device in Russia

276

Alexander Gusev,
Chief Business Development Officer, PhD

The topic of registering software as a medical device remains one of the most relevant in the digital healthcare market. Roszdravnadzor, together with the professional community, created a working group that is operating in the field of targeted changes in legislation on this issue. Their aim is to update it and reduce the complexity and duration of the procedure for registering software as a medical device.

For several years, medical software developers have been undergoing technical and clinical trials of their software products in order to get approval of the Roszdravnadzor. Information about such products is published in the State Register of Medical Devices and Organizations (Private Entrepreneurs) Manufacturing Medical Devices, available at http://www.roszdravnadzor.ru/services/misearch (In Russian).

The problem of the registry is that it is very difficult to get a single list of registered medical software. Therefore, for convenience and clarity, we have created an extract from the register, dividing the found software products into several groups. Please note that we have collected information specifically on independent software products classified as medical devices. Software that is part of hardware and software systems or is a component/accessory to a hardware medical device was not included in our list.

Health (Medical) Information Systems 

The type of Medical Device by the classifier: 157610 - "Application software of the information administrative system for patient registration", 157100 - "Information system for maintaining a patient record", etc.

Product Risk Class   Registry Entry Registration Date
Physician Workstation "Expert System "Kurort-Inform"  1 o5425 05.12.2008
Physician Workstation "Expert System "Kurort-Inform" 1 o3612 19.03.2009
Module "BARS. Zdravookhraneniie-MIS" of the computer program "BARS. Zdravookhraneniie" 23361 15.08.2017
"Infoclinika" medical organization management automation software package 25982 13.02.2018
Medical information system "Ariadna" 25790  10.07.2018
Medical information system qMS for managing the activities of a medical organization 2a 35373 20.12.2019

Laboratory Information Systems

The type of Medical Device by the classifier: 181280 - "Application software for the information system of a clinical laboratory", 182360 - "Interface software for clinical data from medical equipment".

Product Risk Class Registry Entry Registration Data
Software for the automation of clinical and diagnostic laboratory studies "Akross-Clinical Laboratory (ACL)"    o13731 12.05.2011
ALISA software for clinical diagnostic laboratories 1 12710 19.02.2016
Laboratory Automation Software LabForce 14579 05.09.2016
Computer laboratory information system LIS "Innovasystem" 1 15482 05.09.2016
Laboratory information system "Promedichi.LIS" 1 23146 26.05.2017
Laboratory Information System "ALISA" for clinical diagnostic laboratories 25242 02.02.2018
Laboratory information system “1C: Medicine. Clinical laboratory " 25281 09.07.2018
An intermediate level software solution for the exchange and management of data between analyzers, laboratory/medical information systems, electronic health record systems, workstations…. 29755 23.01.2019
Laboratory information system "MEDIALOG" 29338 18.04.2019
Laboratory information system TRAKCARE® LAB Enterprise 37496 18.10.2019
“KMIS.Laboratory"  Software for clinical diagnostic laboratories 36520 19.11.2019

Radiology Information Systems

The type of Medical Device by the classifier: 157300 - "Application software of the information system for maintaining a patient record", 240270 - "Application software for processing DICOM images in radiology", 321450 - "Software for a medical image management system, multidisciplinary", 240320 - "Application software of the information system for radiology", etc.

Product Risk Class  Registry Entry Registration Data
Hardware and software complexes for input, processing and storage of diagnostic information, consisting of: Diagnostician Workstation "Gamma Multivox D1" and an WS of a diagnostician "Gamma Multivox D2"; WS for viewing images "Gamma Multivox P", WSfor a nurse/X-ray technician "Gamma Multivox R" and database server "Gamma Multivox S"  o5207 29.12.2008
Centricity PACS-IW software for acquiring, diagnosing and archiving medical images and data o44229 27.01.2011
Myrian 1.X software package for visualization, processing, archiving and export of medical images and data o45182 11.07.2011
ASTRAIA hardware and software complex for maternity and childhood protection with accessories o45883 18.08.2011
Siemens Syngo Workflow MLR Software - Radiological Information System (RIS) o78922 08.12.2011
IQ-SYSTEM PACS software and hardware complex for receiving, describing, archiving and processing medical images and data and managing system elements with telemedicine functions o81908 17.07.2012
IntelliSpace PACS DCX software for receiving, archiving, distributing, recording and managing medical images o85707 11.04.2013
Software for receiving, viewing, processing, archiving and transferring medical images and data Centricity Universal Viewer Zero Footprint 16174  07.10.2016
Pinnacle3 Radiation Therapy Planning System with Accessories 21899  13.02.2017
Complex of the program "LINS Makhaon DICOM" (PACS-system) 15743, 15745, 15746 07.04.2017, 06.04.2017
Medical diagnostic imaging and analysis software - ResolutionMD 5.1 24212 19.06.2017
Software for viewing, processing, receiving, transferring, storing and archiving ophthalmic images on digital media, versions Merge Eye Care PACS, Merge Eye Station, with accessories 28494 01.08.2018
Centricity Enterprise Archive hardware and software complex for storing diagnostic medical information with accessories 1 31018 26.09.2018
Jemys software package (DICOM server, endoscopic data processing system, RIS) 31763, 31576, 31573 10.12.2018, 20.12.2018
Software for visualization, archiving and export of medical images "INOBITEK" 3070 18.04.2019
Kometa 3Di PACS software package for processing, three-dimensional reconstruction, transmission and storage of medical diagnostic images 36289 04.06.2019
Specialized software "APK ArchiMed" 30374 13.06.2019

Other Information Systems

The type of Medical Device by the classifier: 182360 - "Interface software for clinical data from medical equipment", 190880 - "Application software for a cardiological information system", etc.

Product Risk Class   Registry Entry Registration Data
Communication software between Accu-Chek Connect Device Link and the Accu-Chek Connect Diabetes Web Application 1 25594 29.12.2017
TrichoSciencePro software for the diagnosis of hair and scalp diseases 1 26886 15.03.2018
JEMYS: Telemedicine (version 4.0.1.) software 1 33253 15.02.2019
Information Cardiology Software "TIS" ("Telemedicine information system") 34544 08.11.2019
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