• Regulatory Documents
  • Classifiers and Nomenclatures
  • Measuring Instruments (MI)
  • Import, Entry, and Export of Medical Devices
  • Monitoring
  • Procedure for Handling Unregistered Medical Devices
  • Advertising of Medical Devices
  • Certification
  • Clinical Investigations Involving Human Subjects
  • Information Letters
  • Procurement
  • Localization
  • Special Rules for the Circulation and Registration of Medical Devices
  • Medical Device Software (MDSW)
  • Registers
  • Quality Management System and Inspection
  • Classifiers and Reference Guides
  • Labeling
  • Recommendations
  • Advisory Committee
  • Consulting
  • Reporting
  • Electronic Document Management
  • Licensing
  • Non-Medical Products as Part of Medical Devices
  • Taxation
  • Subsidies and Compensation
  • Registration Certificate Template
  • Criminal and Administrative Liability for Violations in the Field of Medical Device Circulation
  • Procedure for the circulation of unregistered medical devices
  • Checklists
  • Retail Trade, Exchange, Sale of Medical Devices Previously Used, and Replacement of Medical Devices During Repair

Contents

  • Regulatory Documents
  • Information Letters
  • Checklists
  • Classifiers and Nomenclatures
  • Measuring Instruments (MI)
  • Import, Entry, and Export of Medical Devices
  • Monitoring
  • Procedure for Handling Unregistered Medical Devices
  • Procedure for the circulation of unregistered medical devices
  • Retail Trade, Exchange, Sale of Medical Devices Previously Used, and Replacement of Medical Devices During Repair
  • Advertising of Medical Devices
  • Certification
  • Clinical Investigations Involving Human Subjects
  • Procurement
  • Localization
  • Special Rules for the Circulation and Registration of Medical Devices
  • Medical Device Software (MDSW)
  • Registers
  • Quality Management System and Inspection
  • Classifiers and Reference Guides
  • Labeling
  • Recommendations
  • Advisory Committee
  • Consulting
  • Reporting
  • Electronic Document Management
  • Licensing
  • Non-Medical Products as Part of Medical Devices
  • Taxation
  • Subsidies and Compensation
  • Registration Certificate Template
  • Criminal and Administrative Liability for Violations in the Field of Medical Device Circulation

Contents

Resolution of the Government of the Russian Federation No. 1684 of 30.11.2024

On Approval of the Rules for State Registration

of Medical Devices

Decision No. 29 dated 12.02.2016
(as amended on 24.12.2021)

Rules for conducting clinical and clinical-laboratory trials (studies) of medical devices
(Appendix 3 – Requirements for the content of the technical file)

06.01.2023
Read
Resolution of the Government of the Russian Federation No. 323 of 30.06.2004

On Approval of the Regulation on the Federal Service for Surveillance in Healthcare

Regulatory Documents

Russian Federation

EAEU

Read
Read
Read
Read
Federal Law No. 323-FZ of 21.11.2011

Federal Law on the Fundamentals of Health Protection in the Russian Federation

Agreement on the Unified Principles and Rules for the Circulation of Medical Devices (medical-purpose products and medical equipment) within the Eurasian Economic Union

Decision No. 46 of 12.02.2016
(as amended on 19.05.2022 No. 84)

Rules for Registration and Expertise of Safety, Quality, and Effectiveness of Medical Devices
20.06.2023
Read
Read
Order of the Ministry of Health of the Russian Federation No. 181n dated 11.04.2025
“On approval of the requirements for the content of technical and operating documentation of the manufacturer of a medical device”

12.01.2023
Read
Decision No. 27 dated 12.02.2016
General requirements for the safety and performance of medical devices, requirements for their labeling and operating documentation

06.01.2023

Read
Read
Order of the Ministry of Health of the Russian Federation No. 885n dated 30.08.2021

On approval of the Procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological studies, and clinical trials for the purposes of state registration of medical devices
Order of the Ministry of Health of the Russian Federation No. 2n dated 09.01.2014 has been repealed

12.01.2023
Decision No. 38 dated 16.05.2016
(as amended on 17.03.2022)
Rules for conducting studies (tests) to assess the biological effect of medical devices

06.01.2023
Read
Decision No. 28 dated 12.02.2016
(as amended on 17.03.2022)
Rules for conducting technical tests of medical devices

07.01.2023
Document repealed or no longer in force
Document repealed or no longer in force
Read
Decision No. 29 dated 12.02.2016
(as amended on 24.12.2021)
Rules for conducting clinical and clinical-laboratory trials (studies) of medical devices

06.01.2023
Read
Decision No. 116 dated 24.06.2018
Criteria for differentiating elements of medical devices that constitute components of a medical device for the purposes of its registration

28.12.2022
Read
Decision No. 123 dated 24.07.2018
Criteria for including several modifications of a medical device, belonging to the same type of medical device according to the EAEU nomenclature, into a single registration certificate

04.01.2023
Read
Order of the Ministry of Health of the Russian Federation No. 3371 dated 06.05.2019
Administrative Regulation of Roszdravnadzor on the provision of the state service for state registration of medical devices

12.01.2023
Decision No. 177 dated 29.12.2015
Rules for maintaining the
nomenclature of medical devices
Decision No. 46 dated 03.04.2018
On the nomenclature of medical devices
of the Eurasian Economic Union

20.05.2023
Read
Document repealed or no longer in force
Order of the Ministry of Health of the Russian Federation No. 4n dated 06.06.2012
(as amended on 07.07.2020)

On approval of the nomenclature classification
of medical devices

Appendix 2 – Nomenclature Classification

by Risk Classes

Decision No. 80 dated 14.09.2021
(as amended on 14.07.2021)
On approval of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union and the Unified Customs Tariff of the Eurasian Economic Union, as well as on amendments and recognition of certain decisions of the EEC Council as no longer in force

Group 90 – Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and appliances; parts and accessories

07.01.2023
Decision No. 54 dated 16.07.2012
Read
Read
Decision No. 173 dated 22.12.2015

Rules for classification of medical devices
based on potential risk of use

04.01.2023
Order of the Ministry of Health of the Russian Federation No. 4n dated 06.06.2012
(as amended on 07.07.2020)

On approval of the nomenclature classification
of medical devices

Appendix 1 – Nomenclature Classification

Read
Read

EAEU

Russian Federation

Classifiers and Nomenclatures

Read
Resolution of the Government
of the Russian Federation No. 1847 dated 16.11.2020

On approval of the list of measurements subject to state regulation of ensuring the uniformity of measurements
Order of the Ministry of Health of the Russian Federation No. 81n dated 21.02.2014 has been repealed

14.01.2023
Read
Resolution of the Government of the Russian Federation No. 2129 dated 30.11.2021

On approval of the regulation on licensing the activity of technical maintenance of medical devices (except when maintenance is performed to meet the internal needs of a legal entity or individual entrepreneur, and also except maintenance of medical devices with a low potential risk of use), on amendments to Resolution
No. 1445 dated 15.09.2020, and on invalidation of certain acts of the Government of the Russian Federation
Appendix 2 – List of measuring instruments, technical means, and equipment required for maintenance of the declared groups of medical devices by classes of potential risk of use

Order of the Ministry of Health of the Russian Federation No. 321n dated 09.04.2021 has effectively become invalid due to the adoption of the new List and the new Licensing Regulation approved by Resolution No. 2129 dated 30.11.2021

16.01.2023
Read
Decision No. 42 dated 12.02.2016
List of types of MI subject to classification
as measuring instruments during their registration

30.12.2022
Letter of Roszdravnadzor
No. 01И-2118/14 dated 31.12.2014
“On classification as measuring instruments”

28.12.2022
Read

EAEU

Russian Federation

Measuring Instruments (MI)

EAEU

Russian Federation

Resolution of the Government of the Russian Federation No. 1590 dated 22.09.2021
On approval of the Rules for issuing a permit for the entry of a medical device into the territory of the Russian Federation for providing medical care based on vital indications for a specific patient

15.01.2023
Read
Resolution of the Government of the Russian Federation No. 312 dated 09.03.2022

“On the temporary introduction of a permit-based procedure for the export of certain types of goods outside the territory of the Russian Federation”
Order of Roszdravnadzor No. 2075 dated 22.03.2022 (valid until 31.12.2022)

On approval of the Procedure for issuing permits for the export outside the territory of the Russian Federation of certain types of medical-purpose goods in accordance with Appendix No. 6 K

10.01.2023
Information Letter No. 04И-879/22 dated 08.08.2022

Entry of medical devices under a notification procedure

29.12.2022
Read
Read
Order of the Ministry of Health of the Russian Federation No. 201n dated 02.05.2023
“On approval of the Procedure for the entry of medical devices into the territory of the Russian Federation for the purpose of state registration”

Order of the Ministry of Health of the Russian Federation No. 661n dated 30.06.2020 has been repealed
Order of the Ministry of Health of the Russian Federation No. 7n dated 15.06.2012 has been repealed

21.01.2024
Document repealed or no longer in force
Resolution of the Government of the Russian Federation No. 1321 dated 09.08.2021
“On approval of the Rules for the entry of medical devices into the territory of the Russian Federation as specified in paragraphs 1, 2 and 5 of part 5 of Article 38 of the Federal Law ‘On the Basics of Health Protection of Citizens in the Russian Federation’ (except for medical devices specified in subparagraphs ‘a’, ‘v’ and ‘g’ of paragraph 11 of Article 4 of the Agreement on Unified Principles and Rules for the Circulation of Medical Devices (medical-purpose and medical-technical devices) within the Eurasian Economic Union dated 23 December 2014)”

21.01.2024
Read
Read
Order of the Ministry of Industry and Trade of Russia No. 1532 dated 19.04.2022 (as amended on 21.10.2022)
On approval of the list of goods (groups of goods) to which the provisions of subparagraph 6 of Article 1359 and Article 1487 of the Civil Code of the Russian Federation do not apply, provided that the specified goods (groups of goods) are introduced into circulation outside the territory of the Russian Federation by the right holders (patent holders), as well as with their consent

10.01.2023
Read
Read
Decision No. 130 dated 12.11.2021
On the procedure for entry of products into the customs territory of the Eurasian Economic Union that are subject to mandatory conformity assessment in the customs territory of the Eurasian Economic Union

20.05.2023
Read
Decision of the Customs Union Commission No. 526 dated 28.01.2011 (as amended on 21.02.2020)
On the Unified List of Products subject to mandatory requirements within the Customs Union
Item 40 – Medical Devices

09.01.2023

Import, Entry and Export

of Medical Devices

Federal Law No. 248-FZ dated 31.07.2020 (as amended on 14.07.2022) On State Control (Supervision)
and Municipal Control in the Russian Federation

29.12.2022
Read
Resolution of the Government of the Russian Federation No. 1066 dated 30.06.2021 (as amended by Resolution No. 2220 dated 07.12.2021)
On Federal State Control over the Circulation
of Medical Devices

13.01.2023
Read
Resolution of the Government of the Russian Federation No. 1100 dated 30.06.2021 (as amended
on 31.08.2022) On Federal State Epidemiological Control (Supervision)

13.01.2023
Read
Приказ МЗ РФ от 15.09.2020 № 980н
Об утверждении Порядка осуществления мониторинга безопасности медицинских изделий

12.01.2023
Читать
Приказ РЗН от 20 мая 2021 г. N 4513
Об утверждении классификации неблагоприятных событий, связанных с обращением медицинских изделий

11.01.2023
Читать
Читать
Решение от 21.12.2016 года № 141
Об утверждении Порядка применения уполномоченными органами государств-членов Евразийского экономического союза мер по приостановлению или запрету применения медицинских изделий, представляющих опасность для жизни и (или) здоровья людей, недоброкачественных, контрафактных
или фальсифицированных медицинских изделий
и изъятию их из обращения на территориях государств-членов Евразийского экономического союза

09.01.2023
Читать
Решение № 174 от 22.12.2015
Правила проведения мониторинга безопасности, качества и эффективности МИ

16.01.2023
Читать
Решение № 94 от 30.08.2016
Формирование, ведение и использование единой информационной базы данных мониторинга безопасности, качества и эффективности МИ
Единая база данных мониторинга безопасности, качества и эффективности медицинских изделий

04.01.2023
Читать
Руководство по соблюдению обязательных требований законодательства в сфере обращения медицинских изделий от 14.11.2022
Информационные письма о медицинских изделиях
Приказ МЗ РФ от 19.10.2020 № 1113н

Об утверждении Порядка сообщения субъектами обращения медицинских изделий обо всех случаях выявления побочных действий, не указанных
в инструкции по применению или руководстве
по эксплуатации медицинского изделия,
о нежелательных реакциях при его применении,
об особенностях взаимодействия медицинских изделий между собой, о фактах
и об обстоятельствах, создающих угрозу жизни
и здоровью граждан и медицинских работников при применении и эксплуатации медицинских изделий

11.01.2023
Читать

ЕЭАС

Russian Federation

Monitoring

Order of the Ministry of Health
of the Russian Federation No. 368n of 17 July 2023
List of risk indicators of violation of mandatory requirements, used by the Federal Service for Surveillance in Healthcare when exercising federal state control (supervision) over the circulation of medical devices

04.12.2024
Read
Order of Roszdravnadzor No. 1 of 10.01.2022
On approval of the forms of inspection checklists
(lists of control questions, the answers to which indicate compliance or non-compliance by the controlled entity with mandatory requirements), used by the Federal Service for Surveillance in Healthcare and its territorial bodies when exercising federal state control (supervision) over the circulation of medical devices

10.01.2023
Read

EAEU

Russian Federation

Import, importation, and export of medical devices

Checklists

Order of the Ministry of Health
of the Russian Federation No. 1031n of 02.11.2021
Procedure for the manufacture, storage, use, disposal, or destruction of unregistered medical devices
for in vitro diagnostics

12.01.2023
Read
RF Government Decree No. 145 dated February 10, 2022

"On approval of the Rules for withdrawal from circulation and destruction of falsified medical devices, substandard medical devices, and counterfeit medical devices"

21.01.2024
Read
RF Government Decree No. 2026 dated 24.11.2021
(as amended on 26.08.2022)

On Unregistered Medical Devices
for In Vitro Diagnostics
Rules for granting, reissuing, confirming, and revoking permission to use medical devices intended for disease diagnostics through examination of biological material samples from humans outside the body, which are manufactured within a medical organization and used in the same organization that manufactured them.

Government Decree of the Russian Federation No. 2026 dated 24.11.2021 (as amended on 06.11.2024)
"On Unregistered Medical Devices for In Vitro Diagnostics"

(together with:
– “Rules for granting, reissuing, confirming, and revoking permission to use medical devices intended for disease diagnostics through examination of biological material samples from humans outside the body, manufactured and used within the same medical organization”
– “Requirements for medical organizations that manufacture and use such devices”
– “Requirements for medical devices intended for disease diagnostics through examination of biological material samples from humans outside the body, manufactured and used within the same medical organization”)
13.01.2023
Read

EAEU

Russian Federation

Import, importation, and export of medical devices

Procedure for Handling Unregistered Devices

RF Government Decree No. 2463 dated December 31, 2020

On approval of the Rules for the sale of goods under retail sale contracts, the list of long-term use goods not subject to consumer claims for gratuitous replacement during repair or substitution with an equivalent product possessing the same essential consumer properties, and the list of non-food products of proper quality not subject to exchange, as well as amendments to certain acts of the Government of the Russian Federation

List of non-food goods of proper quality not subject to exchange:


















12.01.2023
  1. Goods for prevention and treatment of diseases at home (items for sanitation and hygiene made of metal, rubber, textiles and other materials, medical devices, oral hygiene products, contact lenses, baby care products, medicines).
When retail sales are conducted outside of retail premises by means of direct acquaintance of the consumer with the goods (at home, workplace or school, on transport, in the street, and other locations), sale is not allowed for food products without consumer packaging, as well as for medicines, medical devices, jewelry,
and other products made of precious metals and/or precious stones.
7.
Household electric appliances used for hygiene and medical purposes (electric shavers, clippers, epilators, hair curlers, medical electro-reflectors, heating pads, electric bands, electric blankets, electric toothbrushes, electro massagers, electric hair clippers and other appliances that come into contact with mucous membranes and/or skin).
3.
Used medical devices are not subject to sale. This applies to long-term use products for which the consumer cannot claim a gratuitous substitute during the repair or replacement period if the product has the same essential consumer properties.
30.
Read
Federal Law No. 44-FZ, Article 33, Part 1, Clause 7

The supplied product must be a new product
(a product that has not been used, repaired, restored, had no components replaced, and whose consumer properties have not been restored), unless otherwise specified in the description of the procurement object.
Letter of the Ministry of Finance of the Russian Federation dated 03.06.2020 No. 24-01-08/47511
"On procurement of previously used goods for state (municipal) needs"

20.05.2023
Read

Import, importation, and export of medical devices

Retail trade, exchange, sale of used medical devices, replacement

of medical devices during repair

Federal Law "On Advertising" dated 13.03.2006 No. 38-FZ Art. 24

Advertising of medicinal products, medical devices and medical services, methods of prevention, diagnostics, treatment and medical rehabilitation, methods of traditional medicine

20.05.2023
Read
Letter of Roszdravnadzor dated 02.06.2010 No. 04И-519/10 “On organizing the work of territorial departments
of Roszdravnadzor with information about medical products that do not meet established requirements”
Letter of Roszdravnadzor dated 28 July 2014 No. 01И-1107/14 “On advertising and accompanying
materials on medical devices”
Letter of Roszdravnadzor dated 7 February 2007 No. 03И-104/07 “On advertising of certain types of activities”

Import, importation, and export of medical devices

Advertising of Medical Devices

RF Government Decree dated 23.12.2021 No. 2425

On the approval of a unified list of products subject to mandatory certification, and a unified list of products subject to declaration of conformity, amendments to the Government Decree of the Russian Federation dated 31 December 2020 No. 2467, and recognition of certain acts of the Government of the Russian Federation as no longer in force

Government Decree of the Russian Federation dated 23.12.2021 No. 2425 (as amended on 17.08.2024)
"On the approval of a unified list of products subject to mandatory certification, and a unified list of products subject to declaration of conformity, amendments to the Government Decree of the Russian Federation dated 31 December 2020 No. 2467, and recognition of certain acts of the Government of the Russian Federation as no longer in force"

RF Government Decree dated 01.12.2009 No. 982
is no longer in force

13.01.2023
Read

EAEU

Russian Federation

Import, importation, and export of medical devices

Certification

Order of the Ministry of Health

of the Russian Federation dated 01.03.2013 No. 108
On the approval of the composition of the Ethics Council in the field of medical device circulation

11.01.2023
Read
Order of the Ministry of Health of the Russian Federation dated 08.02.2013 No. 58n
On the approval of the regulation on the Ethics Council in the field of medical device circulation
Order of the Ministry of Health of the Russian Federation dated 11 September 2017 No. 622
"On the network of national medical research centers"
Approvals of the Ethics Council for conducting clinical trials of medical devices (CT of MD) on the website
of the Ministry of Health of the Russian Federation according to national and EAEU rules
Read

EAEU

Russian Federation

Import, importation, and export of medical devices

Clinical trials involving humans

Letter of the Ministry of Health of Russia dated 08.09.2015 No. 2071895/25-3
On the sale of medical devices after the expiration of the registration certificate

28.12.2022
Read
Letter of Roszdravnadzor dated 08.04.2022
No. 01i-376/22
On recommendations for the use and technical maintenance of medical devices

28.12.2022
Read

EAEU

Russian Federation

Import, importation, and export of medical devices

Information letters

RF Government Decree No. 102 dated 05.02.2015
(edited on 08.07.2022)

On restrictions and conditions for the admission
of certain types of medical devices originating from foreign states for the purposes of procurement to meet state and municipal needs decree

Government of the Russian Federation Decree dated 05.02.2015 No. 102 (as amended on 16.09.2023)
"On restrictions and conditions for the admission
of certain types of medical devices originating from foreign states for the purposes of procurement to meet state and municipal needs" (with amendments and additions, effective from 01.01.2024)

15.01.2023
Read
RF Government Decree No. 620 dated 19.04.2021
(edited on 16.03.2022)

On the requirements for forming lots when procuring medical devices that are the object of procurement
for meeting state and municipal needs

Government Decree of the Russian Federation No. 620 dated 19.04.2021 (edited on 12.09.2023)
“On the requirements for forming lots when procuring medical devices that are the object of procurement
for meeting state and municipal needs”

14.01.2023
Read
Read
Decree of the Government of the Russian Federation dated August 22, 2023 No. 1368
On the approval of the rules for forming a list
of medical devices and specialized therapeutic nutrition products required for prescription to
a patient based on medical indications (individual intolerance, vital indications) by decision of a medical commission. This is recorded in the patient's medical documentation and the medical commission’s journal. If described in the list, trademark mention is permitted when purchasing for state and municipal needs.
Order dated October 13, 2023 No. 551н

On the approval of the form for an application
to include a type of medical device and/or group
of specialized therapeutic nutrition products in the list of medical devices and therapeutic nutrition products necessary for patient prescription based on medical indications (individual intolerance, vital indications)
by decision of a medical commission. The decision
is recorded in the patient’s medical documentation and the commission’s journal. The order also approves forms for excluding such types/groups from the list. Mention of trademarks is allowed when describing items for state and municipal procurement.
Decree of the Government of the Russian Federation dated August 29, 2020 No. 1309
On the approval of the rules for forming the list
of medical devices for which maximum ex-factory prices are set, as well as maximum wholesale and
retail markups to the actual ex-factory prices
of manufacturers.

21.01.2024

EAEU

Russian Federation

Import, importation, and export of medical devices

Procurement

RF Government Decree dated July 17, 2015 No. 719
(as amended on 24.09.2022)
On confirmation of industrial production
on the territory of the Russian Federation

16.01.2023
Read
Order of the Ministry of Industry
and Trade dated 20.08.2020 No. 2775
(as amended on 20.09.2022)
On approval of the requirements for the level
of localization of production of telecommunications equipment and the methodology for assessing the localization level of production of telecommunications equipment in order to assign the status
of telecommunications equipment of Russian origin
to telecommunications equipment
RF Government Decree dated 10.07.2019 No. 878
(as amended on 06.12.2021)
On measures to stimulate the production
of radio-electronic products in the territory of the Russian Federation during procurement of goods, works, and services to meet state and municipal needs, on amendments to RF Government Decree dated 16 September 2016 No. 925, and on declaring certain acts of the Government of the Russian Federation
as no longer in force

EAEU

Russian Federation

Import, importation, and export of medical devices

Localization

RF Government Decree dated 03.04.2020 No. 430
(as amended on 28.12.2021)
On the specifics of the circulation of medical devices, including state registration of a series (batch)
of a medical device

13.01.2023
Read
RF Government Decree dated 01.04.2022 No. 552
(as amended on 19.09.2022)
Specifics of circulation, including specifics of state registration of medical devices in the event of their defectiveness or the risk of defectiveness due to the introduction of restrictive economic measures against the Russian Federation

13.01.2023
Read
Order of the Federal Service for Surveillance in Healthcare dated November 13, 2023 No. 8003
"On the establishment of an interdepartmental commission for the formation of a list of types of medical devices to be circulated in accordance with the special rules for circulation, including the specifics of state registration of medical devices in the event of their defectiveness or the risk of defectiveness due to the imposition of restrictive economic measures against the Russian Federation, as approved by the Decree of the Government of the Russian Federation dated April 1, 2022 No. 552, and on the approval of the Regulation on the commission"
Order of the Federal Service for Surveillance in Healthcare dated May 16, 2023 No. 2983

"On the approval of the list of submitted documents and requirements for their content, the form of the conclusion on the possibility (impossibility) of using components or accessories of a medical device not specified in the technical and/or operational documentation of the manufacturer, and the list of information about such components or accessories not specified in the technical and/or operational documentation of the manufacturer to be published on the official website of the Federal State Budgetary Institution 'All-Russian Scientific Research and Testing Institute of Medical Equipment' of the Federal Service for Surveillance in Healthcare in the information and telecommunications network 'Internet'"

EAEU

Russian Federation

Special Rules for the Circulation and Registration of Medical Devices

Recommendations on the acquisition and implementation of medical devices with AI in the GIS3 subsystems of RF constituent entities
Read
Methodological recommendations on the procedure for conducting expertise on the quality, effectiveness, and safety of medical devices (in terms of software)
for state registration within the national system dated 27.10.2020
List of domestic medical devices with AI technologies approved by Roszdravnadzor
Read
Read
Roszdravnadzor Letter No. 02И-297/20 dated 13.02.2020
On software

15.01.2023
Read
RF Government Decree No. 1119 dated 01.11.2012
On approval of requirements for the protection
of personal data during their processing in personal data information systems

13.01.2023
Read
Federal Law No. 152-FZ dated 27.07.2006
(as amended on 14.07.2022)
On personal data

27.12.2022
Read
Federal Law No. 149-FZ dated 27.07.2006
(as amended on 14.07.2022)
On information, information technologies
and the protection of information

27.12.2022

EAEU

Russian Federation

Special Rules for the Circulation and Registration of Medical Devices

RF Government Decree dated 30.09.2021 No. 1650

On the approval of the Rules for maintaining the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices

12.01.2023
Register of medical devices
Read
Read
Read
Decision dated 30.08.2016 No. 92
(as amended on 19.09.2017)
On technological documents regulating information interaction during implementation by means of an integrated information system of external and mutual trade of the general process "formation, maintenance, and use of the unified register of medical devices registered within the Eurasian Economic Union"
Read
Order dated 02.04.2019 No. 56
On the introduction of the general process "Formation, maintenance, and use of the unified register of medical devices registered within the Eurasian Economic Union"
Nomenclature Classification of Medical Devices
by Types
Nomenclature of Medical Devices
of the Eurasian Economic Union
Decision of 30.08.2016 No. 93
(as amended on 24.12.2019)
On technological documents regulating information interaction through the implementation of an integrated information system of external and mutual trade of the general process “formation, maintenance, and use of the unified register of authorized organizations of the Eurasian Economic Union conducting studies (tests) of medical devices for registration purposes”

Read
Order of 12.11.2018 No. 176
Unified register of authorized organizations entitled
to conduct studies (tests) of medical devices
for registration purposes
Testing laboratories (centers) authorized to conduct technical tests of medical devices for registration purposes by the Federal Accreditation Service
Testing laboratories (centers) authorized to conduct technical tests of medical devices for registration within the Eurasian Economic Union (localized in Russia)
Testing laboratories (centers) authorized to conduct toxicological studies (tests) are published on the website of the Federal Accreditation Service
Testing laboratories (centers) authorized to conduct studies (tests) for the assessment of the biological effect of medical devices for registration within the Eurasian Economic Union (localized in Russia)
List of medical organizations conducting
clinical trials of medical devices
Medical organizations authorized to conduct clinical and/or clinical-laboratory trials (studies) of medical devices for registration within the Eurasian Economic Union (localized in Russia)
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Unified register of medical devices registered
within the EAEU
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EAEU

Russian Federation

Registers

Decision No. 106 dated 10.11.2017
(as amended on 19.08.2022)

Requirements for the implementation, maintenance, and assessment of the Quality Management System
for medical devices depending on the potential risk
of their use
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Government Decree of the Russian Federation
dated 09.02.2022 No. 135
Rules for organizing and conducting inspection
of medical device production for compliance with the requirements for the implementation, maintenance, and assessment of the quality management system
for medical devices depending on the potential risk
of their use

24.05.2023
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Government Decree of the Russian Federation
dated 09.02.2022 No. 136
On approval of the requirements
for the implementation, maintenance, and assessment of the quality management system for medical devices depending on the potential risk of their use

15.01.2023
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Decision dated 14.05.2015 No. 29
On the list of general processes within the EAEU
Clause 34.1 Exchange of information on the results
of inspections of the quality management system
of medical device manufacturers
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Order of the Ministry of Health
of the Russian Federation dated 18.02.2022 No. 91n

Methodology for determining the fee for the service
of inspecting the production of medical devices subject to state registration, as well as medical devices manufactured for individual patient orders that include special requirements for the assignment of medical personnel, based on compliance with the requirements for the implementation, maintenance, and evaluation of the quality management system of medical devices depending on the potential risk
12.01.2023
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Order of the Ministry of Health of the Russian Federation dated 21.07.2020 No. 726n

On the approval of the methodology for determining the amount of the fee for the service of assessing the production conditions and quality management system of the medical device manufacturer (production inspection) for compliance with the requirements for the implementation, maintenance, and evaluation of the quality management system of medical devices depending on the potential risk of their use for the purpose of registering medical devices within the framework of the Eurasian Economic Union and determining the amount of the fee for this service
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EAEU

Russian Federation

Quality Management System and Inspection

Decision No. 48 dated 03.04.2018
On the classifier of types of documents in the registration dossier of a medical device
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Decision No. 62 dated 16.04.2019
On the classifier of areas of medical device application
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Decision No. 70 dated 10.05.2018
On the classifier of types of work and services comprising medical activities
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Decision No. 47 dated 03.04.2018
On the classifier of types of adverse events associated with the use of medical devices
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Decision No. 134 dated 21.08.2018
On the reference guide of types of changes introduced into the registration dossier of a medical device
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Decision No. 135 dated 21.08.2018
On the classifier of types of documents issued during the review of the registration dossier of a medical device
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EAEU

Russian Federation

Classifiers

and Reference Guides

Decision No. 26 dated 12.02.2016
On the special mark for circulation of medical devices on the EAEU market
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RF Government Decree No. 515 dated 26.04.2019 
(as amended on 18.04.2020)
On the system of labeling goods by means of identification and tracking of goods movement

13.01.2023
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RF Government Decree No. 137 dated 09.02.2022
On conducting an experiment in the Russian Federation on the labeling of certain types of medical devices using identification means

13.01.2023
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Methodological Guidelines of the Ministry of Industry and Trade of Russia dated 09.06.2022
"Methodological recommendations for conducting an experiment on labeling certain types of medical devices using identification means" 

16.01.2023
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RF Government Order No. 792-r dated 28.04.2018 (as amended on 24.02.2022) 
On the approval of the list of certain goods subject to mandatory labeling with identification means 

10.07.2023
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RF Government Decree No. 1955 dated 31.12.2019 
(as amended on 30.09.2022) 
On ensuring access to information contained in the state information monitoring system for the turnover of goods subject to mandatory labeling with identification means 

12.01.2023
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EAEU

Russian Federation

Labeling

(Marking) Regulations

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Recommendations dated 21.05.2019 No. 14
Methodological recommendations for conducting
an expert examination of the safety, quality, and effectiveness of the registration dossier for medical devices
Methodological recommendations on the procedure for conducting an expert examination of the quality, effectiveness, and safety of medical devices for state registration, approved by the Federal State Budgetary Institution “Center for Monitoring and Expert Examination in Healthcare” (CMEC) of Roszdravnadzor and the Federal State Budgetary Institution “All-Russian Scientific Research and Testing Institute of Medical Equipment” (VNIIMMT) of Roszdravnadzor dated 24.08.2018
Methodological recommendations for the registration of medical devices with a low degree of potential risk 
of their use, included in the list presented in the annex to the Rules for the state registration of medical devices, approved by the Decree of the Government
of the Russian Federation dated 27.12.2012 No. 1416
Recommendations dated 12.11.2018 No. 25
(rev. 29.06.2021)
Criteria for classifying products as medical devices
Recommendation dated 08.10.2019 No. 29

Methodological recommendations on the content and structure of the registration dossier documents
for medical devices
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Recommendation dated 04.09.2017 No. 16

On the procedure for forming a list of standards, the application of which on a voluntary basis fully or partially ensures compliance of medical devices with the General Requirements for the Safety and Effectiveness of Medical Devices, as well as requirements for their labeling and operational documentation
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Recommendation dated 04.09.2017 No. 17
(as amended on 08.06.2021)

On the list of standards, the application of which on
a voluntary basis fully or partially ensures compliance
of medical devices with the General Requirements for the Safety and Effectiveness of Medical Devices, as well as requirements for their labeling and operational documentation
Working group on coordinating the development and maintenance of the nomenclature of medical devices of the Eurasian Economic Union

Includes:
Order of the Board of the Eurasian Economic Commission dated July 26, 2016 No. 109
"On the working group for coordinating the development and maintenance of the nomenclature
of medical devices of the Eurasian Economic Union"

Composition of the working group

Changes in the composition of the working group

List of products excluded from the nomenclature
of medical devices of the Eurasian Economic Union
as non-medical products, formed based on the results of discussions by members of the working group
for coordinating the development and maintenance
of the nomenclature of medical devices of the Eurasian Economic Union

EAEU

Russian Federation

Recommendations

Order of Roszdravnadzor dated 19.07.2017 No. 6478

On approval of the Procedure for the implementation by the Federal State Budgetary Institution "VNIIMT"
of Roszdravnadzor and the Federal State Budgetary Institution "Center for Monitoring and
Clinical-Economic Expertise" of Roszdravnadzor
of consultations on issues related to the state registration procedures of medical devices 

10.01.2023
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Decision No. 123 of 26.09.2017

On the Regulation of the Advisory Committee on Medical Devices
Directive No. 197 of 03.12.2019

On the Composition of the Advisory Committee on Medical Devices
Post-registration clinical safety and effectiveness monitoring report for medical devices

Ministry of Health of the Russian Federation Order dated 19.10.2020 No. 1113
Post-registration clinical safety and effectiveness monitoring report for medical devices

Decision No. 174 dated 22.12.2015
Data on production and shipment of medical devices

Rosstat Order dated 14.04.2017 No. 240
Russian Government Decree No. 430

EAEU

Russian Federation

Advisory Committee

Decision No. 78 dated 30.06.2017
Requirements for the electronic format of applications and registration dossier documents submitted during the registration and examination of the safety, quality, and effectiveness of medical devices

EAEU

Russian Federation

Advisory Committee

EAEU

Russian Federation

Consultation

Order of Roszdravnadzor dated 25.11.2021 No. 11020

Procedure for submission by the manufacturer (its authorized representative) or by a person importing medical devices into the Russian Federation of information to the authorized federal executive authority responsible for control and supervision in the field of healthcare 

10.01.2023
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Order No. 177 dated 12.11.2018
On the implementation of the unified process: “Formation, maintenance and use of a unified information database of safety, quality and effectiveness monitoring of medical devices”
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Decision No. 30 dated 12.02.2016
Procedure for the formation and maintenance of an information system in the field of medical device circulation
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EAEU

Russian Federation

Reporting

Order of Roszdravnadzor dated 16.01.2013
No. 40-Pr/13 (as amended on 10.07.2018)
On approval of the registration certificate
form for a medical device
Decision No. 46 dated 12.02.2016, Annex No. 1
(as amended on 19.05.2022)
Rules for registration and expertise of safety, quality, and effectiveness of medical devices

EAEU

Russian Federation

Registration Certificate Form

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Criminal Code of the Russian Federation

Art. 238.1 Circulation of falsified, substandard, and unregistered medicinal products, medical devices, and circulation of falsified biologically active supplements

Art. 159 Fraud

Art. 178 Restriction of competition

Art. 291 Giving a bribe
Code of Administrative Offenses of the Russian Federation

Art. 6.28 Violation of established rules in the circulation of medical devices

Art. 6.33 Circulation of falsified, counterfeit, substandard, and unregistered medicinal products, medical devices, and circulation of falsified biologically active supplements

Art. 14.3 part 5 Violation of advertising requirements established by law in the advertising of medicinal products, medical devices, and medical services, including treatment methods, as well as biologically active supplements
Decree of the Government of the Russian Federation dated July 16, 2009 No. 584

"On the notification procedure for the commencement of certain types of entrepreneurial activity"

EAEU

Russian Federation

Criminal and Administrative Liability for Violations in the Circulation of Medical Devices

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