Regulatory framework of medical devices circulation in the Eurasian Economic Union (EAEU)

(documents are presented in Russian)

List of acts of the Eurasian Economic Commission on the regulation of common markets of medicines and medical devices within the Eurasian Economic Union in 2017 – 2019		download
On Unified Principles and Rules for Medical Devices (Medical Products and Medical Equipment) Circulation within the Eurasian Economic Union		download (ENG)
Medical device quality management system implementing, maintaining and evaluating requirements depending on the potential application risk (draft, approved by the EEC Board)		download
Rules for monitoring safety, quality and efficacy of medical devices		download
Rules of medical devices nomenclature maintaining		download
Special mark of medical device circulation in the market of the Eurasian Economic Union		download
Rules for clinical and clinical-laboratory testing (research) of medical devices		download
Rules of carrying out technical testing of medical devices		download
Rules of registration and examination of safety, quality and efficacy of medical devices		download
Order of formation and maintaining of an information system in the sphere of medical devices circulation		download
Requirements to the electronic form of statements and documents of registration dossier to be submitted for registration and examination of safety, quality and efficacy of medical devices		download
Rules of medical devices classification according to potential risk of use		download
General requirements of safety and efficacy of medical devices, the requirements for their marking and maintenance documentation on them		download
Formation, maintaining and use of the unified register of authorized organizations of the Eurasian Economic Union, carrying out research (tests) of medical devices in order of their registration		download
Rules of carrying out of research (tests) to assess the biological action of medical devices		download
List of medical devices subject to classification as measuring instruments when registered		download