Organization of Regulatory and Clinical Associates
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Redmond, WA 98073
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Medical Device and IVD Product Registration in Russia. Single Market Within Eurasian Economic Union
Wednesday, April 25, 2018, 8:00 AM until 10:00 AM
is required by April 24, 2018
Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
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TOPICS: Medical Device and IVD Product Registration in Russia/Single Market Within Eurasian Economic Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia)
Medical Device and IVD Product Registration in Russia - Current Procedure
-Market overview (size, facts, figures)
-Basic registration analysis
-Registration process depending on risk class
-Basic understanding of pre-clinical and clinical trials
-Duplicates of and amendments to the existing registration certificate
Single Market of Medical Device and IVD Product Within Eurasian Economic Union (RUS, BEL, KAZ, ARM, KYG) - Expected Changes
-Transition period clarification
-Essential requirements of safety and performance
-Basic understanding of registration process
-Quality Management System requirements
-Safety monitoring (surveillance)
-Comparison of current registration in Russia and EEU procedures
-Critical points of single market
SPEAKERS: Tatiana Nosova, Ruslan Kalachev (BeAWire)
Tatiana Nosova is the CEO at BeAWire Regulatory Affairs Agency. Mrs. Nosova has a M.Sc. in Biomedical Engineering from the Bauman Moscow State Technical University. After graduation, she worked as an RA specialist and then as a Head of RA Department in medical device companies. In the last company she established this activity as new area of company scope. Vast number of manufacturers successfully registered their products under her guidance: Penumbra Inc., Intuitive Surgical Inc. (da Vinci Surgical System), Terumo Corporation, etc. Mrs. Nosova is involved in technical reviews and management of the company.
Ruslan Kalachev is the Director of Strategic Development at BeAWire Regulatory Affairs Agency, which specializes on medical device and IVD product registration in Russia. Mr. Kalachev has a Master Degree in Biomedical Engineering from the Bauman Moscow State Technical University. He worked as an engineer and a sales representative in medical devices companies. His mission in the company is to provide guidance to manufacturers worldwide with regards to the expected regulatory changes. Mr. Kalachev has been an invited speaker at many conferences worldwide (China, Germany, Japan, Korea, Netherlands, USA).
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification