Acts in the sphere of circulation of medical products
Agreement on common principles and rules for the circulation of medical devices
Protocol on making amendments to the Agreement on Unified Principles dated 30 December 2021
Protocol on making amendments to the Agreement on Unified Principles dated 10 June 2022
Protocol on making amendments to the Agreement on Unified Principles dated 13 February 2023
Decisions of the Eurasian Economic Commission's Council
Decision 46 Feb 12, 2016 Rules for Registration and Examination of MP
Decision 144 Dec 24, 2021 On amending the Rules for Marketing Authorization and Expert Examination of Security, Quality and Efficiency of MD
Decision 84 May 19, 2022 On amending the Rules for Marketing Authorization and Expert Examination of MD Security, Quality and Efficiency
Decision 50 March 30, 2023 On amending Decision No. 46 of the EEC's Council dated February 12, 2016
Decision 78 June 30, 2017 Requirements to the Electronic Form of Applications and Documents
Decision 26 Feb 12, 2016 Special Trademark of Circulation of MP
Decision 27 Feb 12, 2016 On Approval of General Requirements for safety and efficacy of MD
Decision 28 Feb 12, 2016 Rules for Technical Testing of MP
Decision 25 March 17, 2022 On Amending the Rules for Technical Testing of MD
Decision 29 Feb 12, 2016 Rules for Clinical and Clinical Laboratory Trials of MP
Decision 146 Dec 24, 2021 Amending Decision No. 29
Decision 30 Feb 12, 2016 Approving the Procedure an Information System in the Field of MD Circulation
Decision 42 Feb 12, 2016 List of Types of MP subject to Assignment to Measuring Instruments
Decision 38 May 16, 2016 Rules for Studies (Tests) for Evaluation of Biological Action
Decision 26 March 17, 2022 On Amending the Rules for Conducting Studies Aimed at the Biological Evaluation of MD
Decision 141 Dec 1212, 2016 Suspend or Prohibit Use of Medical Products
Decision 106 Nov 10, 2017 MP quality management system
Decision 131 Nov 12, 2021 On amending the Requirements for implementing, maintaining and assessing the quality management system of MD
Decision 133 August 19, 2022 On amending the Requirements for implementing, maintaining and assessing the quality management system of MD
Decisions of the Eurasian Economic Commission's Board
Decision 173 Dec 22, 2015 Rules for Classification of Medical Products
Decision 65 May 23, 2023 On amending the Rules for Classification of MD and on canceling certain decisions
Decision 174 Dec 22, 2015 Rules for the Monitoring of MP
Decision 177 Dec 29, 2015 Rules for Keeping Medical Product Nomenclature
Decision 123 Sep 26, 2017 On Regulation on the Advisory Committee for MD
Recommendations of the Eurasian Economic Commission's Board
Recommendation 16 Sep 4, 2017 Procedure for formation of the list of standards
Recommendation 17 Sep 4, 2017 On the list of standards
Recommendation 10 June 8, 2021 On amending the List of Standards Applying which on Voluntary Basis Will Result in Compliance of MD
Recommendation 15 June 27, 2023 On amending the List of Standards Applying which on Voluntary Basis Will Result in Compliance of MD
Recommendation 25 Nov 12, 2018 Criteria for Classifying Products as MD
Recommendation 22 Sep 13, 2021 Guidelines for Assessing and Authorizing Organizations to Inspect
Recommendation 6 March 28, 2023 Common approaches to the activities of organizations authorized to inspect
Protocol on making amendments to the Agreement on Unified Principles dated 30 December 2021
Protocol on making amendments to the Agreement on Unified Principles dated 10 June 2022
Protocol on making amendments to the Agreement on Unified Principles dated 13 February 2023
Decisions of the Eurasian Economic Commission's Council
Decision 46 Feb 12, 2016 Rules for Registration and Examination of MP
Decision 144 Dec 24, 2021 On amending the Rules for Marketing Authorization and Expert Examination of Security, Quality and Efficiency of MD
Decision 84 May 19, 2022 On amending the Rules for Marketing Authorization and Expert Examination of MD Security, Quality and Efficiency
Decision 50 March 30, 2023 On amending Decision No. 46 of the EEC's Council dated February 12, 2016
Decision 78 June 30, 2017 Requirements to the Electronic Form of Applications and Documents
Decision 26 Feb 12, 2016 Special Trademark of Circulation of MP
Decision 27 Feb 12, 2016 On Approval of General Requirements for safety and efficacy of MD
Decision 28 Feb 12, 2016 Rules for Technical Testing of MP
Decision 25 March 17, 2022 On Amending the Rules for Technical Testing of MD
Decision 29 Feb 12, 2016 Rules for Clinical and Clinical Laboratory Trials of MP
Decision 146 Dec 24, 2021 Amending Decision No. 29
Decision 30 Feb 12, 2016 Approving the Procedure an Information System in the Field of MD Circulation
Decision 42 Feb 12, 2016 List of Types of MP subject to Assignment to Measuring Instruments
Decision 38 May 16, 2016 Rules for Studies (Tests) for Evaluation of Biological Action
Decision 26 March 17, 2022 On Amending the Rules for Conducting Studies Aimed at the Biological Evaluation of MD
Decision 141 Dec 1212, 2016 Suspend or Prohibit Use of Medical Products
Decision 106 Nov 10, 2017 MP quality management system
Decision 131 Nov 12, 2021 On amending the Requirements for implementing, maintaining and assessing the quality management system of MD
Decision 133 August 19, 2022 On amending the Requirements for implementing, maintaining and assessing the quality management system of MD
Decisions of the Eurasian Economic Commission's Board
Decision 173 Dec 22, 2015 Rules for Classification of Medical Products
Decision 65 May 23, 2023 On amending the Rules for Classification of MD and on canceling certain decisions
Decision 174 Dec 22, 2015 Rules for the Monitoring of MP
Decision 177 Dec 29, 2015 Rules for Keeping Medical Product Nomenclature
Decision 123 Sep 26, 2017 On Regulation on the Advisory Committee for MD
Recommendations of the Eurasian Economic Commission's Board
Recommendation 16 Sep 4, 2017 Procedure for formation of the list of standards
Recommendation 17 Sep 4, 2017 On the list of standards
Recommendation 10 June 8, 2021 On amending the List of Standards Applying which on Voluntary Basis Will Result in Compliance of MD
Recommendation 15 June 27, 2023 On amending the List of Standards Applying which on Voluntary Basis Will Result in Compliance of MD
Recommendation 25 Nov 12, 2018 Criteria for Classifying Products as MD
Recommendation 22 Sep 13, 2021 Guidelines for Assessing and Authorizing Organizations to Inspect
Recommendation 6 March 28, 2023 Common approaches to the activities of organizations authorized to inspect