Resolution of the Government of the Russian Federation No. 1042 dated 30 September 2015 (as amended on 15 August 2019)
On Approval of the List of Medical Goods Whose Sale in the Russian Federation and Import into the Russian Federation and Other Territories under Its Jurisdiction Are Exempt from Value Added Tax.
Resolution of the Government of the Russian Federation No. 1054 dated 15 August 2019
On Amendments to the List of Medical Goods Whose Sale in the Russian Federation and Import into the Russian Federation and Other Territories under Its Jurisdiction Are Exempt from Value Added Tax.
Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union. Agreement dated 23 December 2014
Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union. Agreement dated 23 December 2014
Protocol Amending the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union dated 23 December 2014.
Protocol Amending the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union dated 23 December 2014.
EEC Council Decision No. 46 dated 12 February 2016
On the Rules for Registration and Expert Review of the Safety, Quality and Effectiveness of Medical Devices.
EEC Council Decision No. 26 dated 12 February 2016
On the Special Mark for Circulation of Medical Devices in the Eurasian Economic Union Market.
EEC Council Decision No. 27 dated 12 February 2016
On Approval of the General Safety and Performance Requirements for Medical Devices and Requirements for Their Labeling and Operating Documentation.
EEC Council Decision No. 28 dated 12 February 2016
On Approval of the Rules for Conducting Technical Testing of Medical Devices.
EEC Council Decision No. 29 dated 12 February 2016
On the Rules for Conducting Clinical and Clinical-Laboratory Trials (Studies) of Medical Devices.
EEC Council Decision No. 30 dated 12 February 2016
On Approval of the Rules for Conducting Studies (Tests) to Assess the Biological Effects of Medical Devices.
EEC Council Decision No. 38 dated 16 May 2016
On Approval of the Rules for Conducting Studies (Tests) to Assess the Biological Effects of Medical Devices.
EEC Council Decision No. 42 dated 12 February 2016
On Approval of the List of Medical Device Types to Be Classified as Measuring Instruments during Registration.
EEC Council Decision No. 106 dated 10 November 2017
On Requirements for the Implementation, Maintenance and Assessment of Medical Device Quality Management Systems Depending on the Potential Risk of Use.
EEC Board Decision No. 116 dated 24 July 2018
On Criteria for Distinguishing Medical Device Elements That Constitute Components of a Medical Device for Registration Purposes.
EEC Board Decision No. 123 dated 24 July 2018
On Criteria for Including Several Modifications of a Medical Device Belonging to the Same Type under the EAEU Medical Device Nomenclature in a Single Registration Certificate.
EEC Board Decision No. 173 dated 22 December 2015
On Approval of the Rules for Classification of Medical Devices Depending on Potential Risk of Use.
EEC Board Decision No. 174 dated 22 December 2015
On Approval of the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices
EEC Board Decision No. 177 dated 29 December 2015
On the Rules for Maintaining the Medical Device Nomenclature.
EEC Board Recommendation No. 14 dated 21 May 2019
On Methodological Recommendations for Expert Review of the Safety, Quality and Effectiveness of Medical Devices for Registration within the Eurasian Economic Union.
EEC Board Recommendation No. 16 dated 4 September 2017
On the Procedure for Forming the List of Standards Whose Voluntary Application Fully or Partially Ensures Compliance of Medical Devices with the General Safety and Performance Requirements and with Labeling and Operating-Documentation Requirements.
EEC Board Recommendation No. 17 dated 4 September 2017
On the List of Standards Whose Voluntary Application Fully or Partially Ensures Compliance of Medical Devices with the General Safety and Performance Requirements and with Labeling and Operating-Documentation Requirements.
EEC Board Recommendation No. 25 dated 12 November 2018
On Criteria for Classifying Products as Medical Devices within the Eurasian Economic Union.
EEC Board Recommendation No. 15 dated 29 June 2021 (supplement to Recommendation No. 25)
On Amendments to the Criteria for Classifying Products as Medical Devices within the Eurasian Economic Union.
EEC Board Recommendation No. 29 dated 8 October 2019
On Methodological Recommendations Concerning the Content and Structure of Medical Device Registration-Dossier Documents.
Order of the Ministry of Health of the Russian Federation No. 726n dated 21 July 2020
On Approval of the Methodology for Determining the Fee for Assessment of Manufacturing Conditions and the Medical Device Manufacturer’s Quality Management System (Manufacturing-Site Inspection) for Compliance with EAEU Requirements, and the Maximum Fee for Such Service.
Resolution of the Government of the Russian Federation No. 633 dated 31 May 2018
On Amendments to the Rules for Registration of Medical Devices.
Resolution of the Government of the Russian Federation No. 1416 dated 27 December 2012
On Approval of the Rules for State Registration of Medical Devices.
Order of the Ministry of Health of the Russian Federation No. 885n dated 30 August 2021
On Approval of the Procedure for Conformity Assessment of Medical Devices in the Form of Technical Testing, Toxicological Studies and Clinical Trials for State Registration of Medical Devices (replacing Ministry of Health Order No. 2n).
Order of the Ministry of Health of the Russian Federation No. 4n dated 6 June 2012
On Approval of the Nomenclature Classification of Medical Devices.
Order of the Ministry of Health of the Russian Federation No. 686n dated 7 July 2020
On Amendments to Appendices Nos. 1 and 2 to Ministry of Health Order No. 4n dated 6 June 2012 “On Approval of the Nomenclature Classification of Medical Devices.”
Order of the Ministry of Health of the Russian Federation No. 11n dated 19 January 2017
On Approval of Requirements for the Content of the Manufacturer’s Technical and Operating Documentation for a Medical Device.
Order of the Ministry of Health of the Russian Federation No. 206n dated 20 March 2020
On Approval of the Procedure for Organizing and Conducting Expert Review of the Quality, Effectiveness and Safety of Medical Devices.
Order of the Ministry of Health of the Russian Federation No. 661n dated 30 June 2020
On Approval of the Procedure for Importing Medical Devices into the Russian Federation for State Registration Purposes.
Resolution of the Government of the Russian Federation No. 430 dated 3 April 2020
On Special Rules for the Circulation of Medical Devices, Including State Registration of a Series (Batch) of a Medical Device.
Resolution of the Government of the Russian Federation No. 552 dated 1 April 2022
On Special Rules for the Circulation, Including State Registration, of Medical Devices in the Event of a Shortage or Risk of Shortage Related to Economic Restrictive Measures against the Russian Federation.
Resolution of the Government of the Russian Federation No. 804 dated 2 June 2020
On Amendments to the Special Rules for the Circulation of Medical Devices, Including State Registration of a Series (Batch) of a Medical Device.
Roszdravnadzor Order No. 3371 dated 6 May 2019
On Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for Provision of the State Service of State Registration of Medical Devices.
Resolution of the Government of the Russian Federation No. 135 dated 9 February 2022
On Approval of the Rules for Organizing and Conducting Inspections of Medical Device Manufacturing for Compliance with Requirements for the Implementation, Maintenance and Assessment of the Medical Device Quality Management System Depending on Potential Risk of Use.
Resolution of the Government of the Russian Federation No. 136 dated 9 February 2022
On Approval of Requirements for the Implementation, Maintenance and Assessment of the Medical Device Quality Management System Depending on Potential Risk of Use.
Federal Law No. 323-FZ dated 21 November 2011
On the Fundamentals of Public Health Protection in the Russian Federation.
Roszdravnadzor Order No. 11205 dated 30 November 2020
On Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for Provision of the State Service of Issuing Permits to Import Medical Devices into the Russian Federation for State Registration Purposes.
Order of the Ministry of Health of the Russian Federation No. 11n dated 19 January 2017
On Approval of Requirements for the Content of the Manufacturer’s Technical and Operating Documentation for a Medical Device.
Order of the Ministry of Health of the Russian Federation No. 206n dated 20 March 2020
On Approval of the Procedure for Organizing and Conducting Expert Review of the Quality, Effectiveness and Safety of Medical Devices.
EEC Board Recommendation No. 29 dated 8 October 2019
On Methodological Recommendations Concerning the Content and Structure of Medical Device Registration-Dossier Documents.
GOST R ISO 15223-1-2023
Medical Devices — Symbols to Be Used with Information to Be Supplied by the Manufacturer — Part 1: General Requirements.
BS EN ISO 80369-7:2017
Small-Bore Connectors for Liquids and Gases in Healthcare Applications.
GOST R 50444-2020
Medical Instruments, Apparatus and Equipment — General Technical Requirements.
GOST R IEC 62366-1-2023
Medical Devices — Part 1: Application of Usability Engineering to Medical Devices.
GOST IEC 62304-2022
Medical Device Software — Software Life-Cycle Processes.
GOST R IEC 60601-1-2-2014
Medical Electrical Equipment — Part 1-2: General Requirements for Basic Safety and Essential Performance — Collateral Standard: Electromagnetic Compatibility — Requirements and Tests.
GOST 31214-2016
Requirements for Samples and Documentation Submitted for Toxicological and Sanitary-Chemical Studies and for Sterility and Pyrogenicity Testing.
GOST R 52770-2023
Safety Requirements — Methods for Sanitary-Chemical and Toxicological Testing.
GOST ISO 10993-1-2021
Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing within a Risk Management Process.
GOST R ISO 10993-2-2009
Biological Evaluation of Medical Devices — Part 2: Animal Welfare Requirements.
GOST ISO 10993-3-2011
Biological Evaluation of Medical Devices — Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity.
GOST ISO 10993-4-2020
Biological Evaluation of Medical Devices — Part 4: Selection of Tests for Interactions with Blood.
GOST ISO 10993-5-2023
Biological Evaluation of Medical Devices — Part 5: Tests for In Vitro Cytotoxicity.
GOST ISO 10993-6-2011
Biological Evaluation of Medical Devices — Part 6: Tests for Local Effects after Implantation.
GOST ISO 10993-7-2016
Biological Evaluation of Medical Devices — Part 7: Ethylene Oxide Sterilization Residuals.
GOST ISO 10993-9-2015
Biological Evaluation of Medical Devices — Part 9: Framework for Identification and Quantification of Potential Degradation Products.
GOST ISO 10993-10-2023
Biological Evaluation of Medical Devices — Part 10: Tests for Skin Sensitization.
GOST ISO 10993-11-2021
Biological Evaluation of Medical Devices — Part 11: Tests for Systemic Toxicity.
GOST ISO 10993-12-2015
Biological Evaluation of Medical Devices — Part 12: Sample Preparation and Reference Materials.
GOST ISO 10993-23-2023
Biological Evaluation of Medical Devices — Part 23: Tests for Irritation.
General Pharmacopoeial Monograph OFS.1.2.4.0003.15 — Sterility
This general pharmacopoeial monograph covers sterility-test methods for medicinal products, including injection and infusion preparations, eye drops, films, pharmaceutical substances and excipients, including biological medicinal products and their solvents, that are required by applicable documentation or pharmacopoeial monographs to be sterile.
General Pharmacopoeial Monograph OFS.1.2.3.0005.15 — Pyrogenicity
This general pharmacopoeial monograph covers pyrogenicity testing of injectable solutions and pharmaceutical substances used to manufacture them. The test is based on measuring rabbit body temperature before and after injection.
GOST ISO 17511-2011
In Vitro Diagnostic Medical Devices — Measurement of Quantities in Biological Samples — Metrological Traceability of Values Assigned to Calibrators and Control Materials.
GOST R 51352-2013
In Vitro Diagnostic Medical Devices — Test Methods.
GOST R 52361-2005
Analytical Control — Terms and Definitions.
GOST R ISO 5725-1-2002
Accuracy (Trueness and Precision) of Measurement Methods and Results.
GOST R ISO 15193-2007
In Vitro Diagnostic Medical Devices — Measurement of Quantities in Samples of Biological Origin — Requirements for Content and Presentation of Reference Measurement Procedures.
GOST R EN 13612-2010
Performance Evaluation of In Vitro Diagnostic Medical Devices.
GOST R ISO 18153-2006
In Vitro Diagnostic Medical Devices — Measurement of Quantities in Biological Samples — Metrological Traceability of Values for Catalytic Concentration of Enzymes Assigned to Calibrators and Control Materials.
GOST R ISO 15194-2007
In Vitro Diagnostic Medical Devices — Measurement of Quantities in Samples of Biological Origin — Requirements for Certified Reference Materials and Supporting Documentation.
GOST R ISO 23640-2015
In Vitro Diagnostic Medical Devices — Evaluation of Stability of In Vitro Diagnostic Reagents.
GOST IEC 62304-2022
Medical Device Software — Software Life-Cycle Processes.
Methodological Recommendations — Software
Methodological Recommendations on the Procedure for Expert Review of the Quality, Effectiveness and Safety of Medical Devices, in the Part Relating to Software, for State Registration under the National System.
Resolution of the Government of the Russian Federation No. 633 dated 31 May 2018
On Amendments to the Rules for Registration of Medical Devices.
Resolution of the Government of the Russian Federation No. 1416 dated 27 December 2012
On Approval of the Rules for State Registration of Medical Devices.
Order of the Ministry of Health of the Russian Federation No. 206n dated 20 March 2020
On Approval of the Procedure for Organizing and Conducting Expert Review of the Quality, Effectiveness and Safety of Medical Devices.
Methodological Recommendations — Software
Methodological Recommendations on the Procedure for Expert Review of the Quality, Effectiveness and Safety of Medical Devices, in the Part Relating to Software, for State Registration under the National System.
Methodological Guidelines on the Expert-Review Procedure
Methodological Guidelines on the Procedure for Expert Review of the Quality, Effectiveness and Safety of Medical Devices for State Registration.
EEC Board Recommendation No. 14 dated 21 May 2019
On Methodological Recommendations for Expert Review of the Safety, Quality and Effectiveness of Medical Devices for Registration within the Eurasian Economic Union.
EEC Board Recommendation No. 29 dated 8 October 2019
On Methodological Recommendations Concerning the Content and Structure of Medical Device Registration-Dossier Documents.
GOST R ISO 15223-1-2023
Medical Devices — Symbols to Be Used with Information to Be Supplied by the Manufacturer — Part 1: General Requirements.
EEC Council Decision No. 26 dated 12 February 2016
On the Special Mark for Circulation of Medical Devices in the Eurasian Economic Union Market.
Resolution of the Government of the Russian Federation No. 1042 dated 30 September 2015 (as amended on 15 August 2019)
On Approval of the List of Medical Goods Whose Sale in the Russian Federation and Import into the Russian Federation and Other Territories under Its Jurisdiction Are Exempt from Value Added Tax.
EEC Council Decision No. 27 dated 12 February 2016
On Approval of the General Safety and Performance Requirements for Medical Devices and Requirements for Their Labeling and Operating Documentation.
Information on Re-sterilization of medical devices
Information on re-sterilization of medical devices
Methodological guidelines on disinfection and sterilization
Methodological guidelines on disinfection and sterilization
GOST ISO 10993-7-2016
Biological Evaluation of Medical Devices — Part 7: Ethylene Oxide Sterilization Residuals.
Companies
Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.
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