Regulatory Documents

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

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

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

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

07.01.2023

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

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

Document repealed or no longer in force

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

Document repealed or no longer in force

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

Document repealed or no longer in force

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of the Eurasian Economic Union, as well as on amendments and recognition of certain decisions of the EEC Council as no longer in force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

Decision No. 173 dated 22.12.2015

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

04.01.2023

EAEU

Classifiers and Nomenclatures

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

30.12.2022

EAEU

Measuring Instruments (MI)

Decision No. 141 of 21 December 2016
On Approval of the Procedure for the Application by the Authorized Bodies of the Member States of the Eurasian Economic Union of Measures for Suspension or Prohibition of the Use of Medical Devices that Pose a Threat to Human Life and/or Health, of Substandard, Counterfeit or Falsified Medical Devices, and for Their Withdrawal from Circulation within the Territories of the Member States of the Eurasian Economic Union

09.01.2023

Decision No. 174 of 22 December 2015
Rules for Conducting Safety, Quality, and Performance Monitoring of Medical Devices

16.01.2023

Decision No. 94 of 30 August 2016
Formation, Maintenance, and Use of the Unified Information Database for Monitoring the Safety, Quality, and Performance of Medical Devices
Unified Database for Monitoring the Safety, Quality, and Performance of Medical Devices

04.01.2023

ЕЭАС

Monitoring

Ethics Council Approvals for Conducting Clinical Trials of Medical Devices on the Website of the Ministry of Health of the Russian Federation under National Rules and under the Rules of the Eurasian Economic Union (EAEU)

EAEU

Clinical Studies

Involving Human Subjects

Unified Register of Medical Devices Registered within the Eurasian Economic Union / Registration Certificates

Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration

Decision No. 92 of 30 August 2016 (as amended on 19 September 2017)

On Technological Documents Regulating Information Interaction in the Implementation, through the Integrated Information System of Foreign and Mutual Trade, of the Common Process “Formation, Maintenance, and Use of the Unified Register of Medical Devices Registered within the Eurasian Economic Union”

Directive No. 56 of 2 April 2019

On the Implementation of the Common Process “Formation, Maintenance, and Use of the Unified Register of Medical Devices Registered within the Eurasian Economic Union”

Decision No. 93 of 30 August 2016 (as amended on 24 December 2019)

On Technological Documents Regulating Information Interaction in the Implementation, through the Integrated Information System of Foreign and Mutual Trade, of the Common Process “Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration”

Directive No. 176 of 12 November 2018

Unified Register of Authorized Organizations Entitled to Conduct Studies (Tests) of Medical Devices for the Purpose of Their Registration

Testing Laboratories (Centers) Authorized to Conduct Technical Tests of Medical Devices for the Purpose of Their Registration within the Eurasian Economic Union (Localization in Russia)

Testing Laboratories (Centers)
Authorized to Conduct Studies (Tests)
for the Purpose of Assessing the Biological Effect of Medical Devices for Their Registration within the Eurasian Economic Union (Localization in Russia)

Medical Organizations Authorized to Conduct Clinical and/or Clinical-Laboratory Trials (Studies) of Medical Devices for the Purpose of Their Registration within the Eurasian Economic Union (Localization in Russia)

Nomenclature of Medical Devices of the Eurasian Economic Union

EAEU

Registers

Decision No. 106 of 10 November 2017 (as amended on 19 August 2022)

Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System of Medical Devices Depending on the Potential Risk of Their Use

Decision No. 29 of 14 May 2015

On the List of Common Processes within the Eurasian Economic Union Clause 34.1 Exchange of Information on the Results of Inspection of Quality Management Systems of Medical Device Manufacturers

Order of the Ministry of Health of the Russian Federation No. 726n of 21 July 2020

On Approval of the Methodology for Determining the Fee for the Service of Assessing the Manufacturing Conditions and the Quality Management System of a Medical Device Manufacturer (Manufacturing Site Inspection) for Compliance with the Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System of Medical Devices Depending on the Potential Risk of Their Use for the Purpose of Registration of Medical Devices within the Eurasian Economic Union, and on the Maximum Fee for the Provision of Such Service

EAEU

Quality Management

System and Inspection

Decision No. 48 of 3 April 2018

On the Classifier of Document Types of the Medical Device Registration Dossier

Decision No. 62 of 16 April 2019

On the Classifier of Medical Application Areas of Medical Devices

Decision No. 70 of 10 May 2018

On the Classifier of Types of Work and Services Constituting Medical Activities

Decision No. 47 of 3 April 2018

On the Classifier of Types of Adverse Events Associated with the Use of Medical Devices

Decision No. 134 of 21 August 2018

On the Reference Guide of Types of Amendments Introduced into the Medical Device Registration Dossier

Decision No. 135 of 21 August 2018

On the Classifier of Types of Documents Issued during the Review of the Medical Device Registration Dossier

EAEU

Classifiers and Reference Guides

Decision No. 26 of 12 February 2016

On the Special Mark for Circulation of Medical Devices in the EAEU Market

EAEU

Labeling

(Marking) Regulations

Recommendations No. 14 of 21 May 2019

Methodological Guidelines for Conducting Expert Review of the Safety, Quality, and Performance of the Medical Device Registration Dossier

Recommendations No. 25 of 12 November 2018
(as amended on 29 June 2021)

Criteria for Classification of Products as Medical Devices

Recommendation No. 29 of 8 October 2019

Methodological Guidelines on the Content and Structure of Documents of the Medical Device Registration Dossier

Recommendation No. 16 of 4 September 2017

On the Procedure for Forming 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 Safety and Performance of Medical Devices, as well as with the Requirements for Their Labeling and Operating Documentation

Recommendation No. 17 of 4 September 2017
(as amended on 8 June 2021)

On the List of Standards, the Results of Application of Which on a Voluntary Basis Fully or Partially Ensure Compliance of Medical Devices with the General Requirements for Safety and Performance of Medical Devices, as well as with the Requirements for Their Labeling and Operating Documentation

Document repealed or no longer in force

Working Group for Coordination of Activities on the Development and Maintenance of the Nomenclature of Medical Devices of the Eurasian Economic Union
Contains:

Order of the Board of the Eurasian Economic Commission
No. 109 of 26 July 2016
“On the Working Group for Coordination of Activities on the Development and Maintenance of the Nomenclature of Medical Devices of the Eurasian Economic Union”
Composition of the Working Group

Amendments to 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 Review by the Members of the Working Group for Coordination of Activities on the Development and Maintenance of the Nomenclature of Medical Devices of the Eurasian Economic Union

EAEU

Recommendations

Decision No. 123 of 26 September 2017

On the Regulations of the Advisory Committee on Medical Devices

Directive No. 197 of 3 December 2019

On the Composition of the Advisory Committee on Medical Devices

Advisory Committee

EAEU

Decision No. 174 of 22 December 2015

Post-Registration Clinical Monitoring Report on the Safety and Clinical Performance of Medical Devices

Order of Roszdravnadzor No. 11020 of 25 November 2021

Procedure for Submission by the Manufacturer (Producer) of a Medical Device (Its Authorized Representative) or by a Person Importing Medical Devices into the Territory of the Russian Federation of Information to the Authorized Federal Executive Authority Performing Control and Supervision Functions in the Field of Public Health

EAEU

Reporting

EAEU

Decision No. 78 of 30 June 2017

Requirements for the Electronic Format of Applications and Documents of the Registration Dossier Submitted during the Registration and Expert Review of the Safety, Quality, and Performance of Medical Devices

Electronic Document Management

Directive No. 177 of 12 November 2018

On the Implementation of the Common Process “Formation, Maintenance, and Use of the Unified Information Database for Monitoring the Safety, Quality, and Performance of Medical Devices”

Decision No. 30 of 12 February 2016

Procedure for the Formation and Maintenance of the Information System in the Field of Circulation of Medical Devices

EAEU

EAEU