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" | 2а | 23361 | 15.08.2017 |
| "Infoclinika" medical organization management automation software package | 2а | 25982 | 13.02.2018 |
| Medical information system "Ariadna" | 2а | 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)" | 2а | o13731 | 12.05.2011 |
| ALISA software for clinical diagnostic laboratories | 1 | 12710 | 19.02.2016 |
| Laboratory Automation Software LabForce | 2а | 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 | 2а | 25242 | 02.02.2018 |
| Laboratory information system “1C: Medicine. Clinical laboratory " | 2а | 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…. | 2а | 29755 | 23.01.2019 |
| Laboratory information system "MEDIALOG" | 2а | 29338 | 18.04.2019 |
| Laboratory information system TRAKCARE® LAB Enterprise | 2а | 37496 | 18.10.2019 |
| “KMIS.Laboratory" Software for clinical diagnostic laboratories | 2а | 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" | 2а | o5207 | 29.12.2008 |
| Centricity PACS-IW software for acquiring, diagnosing and archiving medical images and data | 2а | o44229 | 27.01.2011 |
| Myrian 1.X software package for visualization, processing, archiving and export of medical images and data | 2а | o45182 | 11.07.2011 |
| ASTRAIA hardware and software complex for maternity and childhood protection with accessories | 2а | o45883 | 18.08.2011 |
| Siemens Syngo Workflow MLR Software - Radiological Information System (RIS) | 2а | 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 | 2а | o81908 | 17.07.2012 |
| IntelliSpace PACS DCX software for receiving, archiving, distributing, recording and managing medical images | 2а | o85707 | 11.04.2013 |
| Software for receiving, viewing, processing, archiving and transferring medical images and data Centricity Universal Viewer Zero Footprint | 2а | 16174 | 07.10.2016 |
| Pinnacle3 Radiation Therapy Planning System with Accessories | 2б | 21899 | 13.02.2017 |
| Complex of the program "LINS Makhaon DICOM" (PACS-system) | 2а | 15743, 15745, 15746 | 07.04.2017, 06.04.2017 |
| Medical diagnostic imaging and analysis software - ResolutionMD 5.1 | 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 | 2а | 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) | 2б | 31763, 31576, 31573 | 10.12.2018, 20.12.2018 |
| Software for visualization, archiving and export of medical images "INOBITEK" | 2а | 3070 | 18.04.2019 |
| Kometa 3Di PACS software package for processing, three-dimensional reconstruction, transmission and storage of medical diagnostic images | 2б | 36289 | 04.06.2019 |
| Specialized software "APK ArchiMed" | 2б | 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") | 2а | 34544 | 08.11.2019 |