First registration certificate under EAEU regulation was issued in the end of December 2019: registration certificate is in action inside Russia and Kyrgyzstan, for medical device made in Russia
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Main information from yesterday seminar provided by FGBU CMIKEE about EAC MED mark
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A list of standards which, on a voluntary basis, fully or partially ensure compliance of medical devices with the General requirements of safety and efficacy of medical devices, the requirements for their labeling and maintenance documents approved by the recommendation of the Eurasian Economic Commission panel. You could find recommendation #17 by link (in English) – EAC #17 (standards) ; (in Russian)
Read moreThe Federal Service for Surveillance in Healthcare (Roszdravnadzor) holds a workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union”. A workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union” was held in Moscow
Read more“Approved once, accepted everywhere” – main idea for EEU medical regulatory affairs. Expected regulation for all medical devices has a lot of unknowns: 1. Harmonization – base of acceptance criteria- is still in process. 2. Classification rules for medical devices – different for each country for this moment and only Russia has clear nomenclature (4n classification rules). 3. Acceptance process
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