Table of Contents
Medical Device Registration in EAEU (RUSSIA, BELARUS, ARMENIA, KAZAKHSTAN
AND KYRGYZSTAN)
THE TRANSITION PERIOD ON THE MEDICAL PRODUCTS MARKET
THE EAEU INCLUDES RUSSIA, BELARUS, ARMENIA, KAZAKHSTAN
AND KYRGYZSTAN
IN 2016 THE COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
ESTABLISHED NEW RULES FOR THE REGISTRATION OF MEDICAL
DEVICES, AND ALL EAEU MEMBER STATES MUST FOLLOW THESE
RULES AT THE MOMENT, ALL COUNTRIES HAVE THEIR OWN (
RULES FOR THE REGISTRATION OF MEDICAL PRODUCTS, AND
MANUFACTURERS MUST UNDERGO SEPARATE REGISTRATION IN
EACH STATE FROM JANUARY 1 2022 REGISTRATION UNDER THE RULES OF THE EAEU WILL BECOME MANDATORY
THE PROCEDURE WILL BE THE SAME FOR EVERYONE, AND A
COMMON MARKET FOR THE CIRCULATION OF MEDICAL DEVICES
WILL APPEAR ON THE TERRITORY OF THE EAEU
Registration in EAEU. Process overview.
Differences in approval path depending on type and classification
Timeline
About Registration Certificate
About Registration Certificate
1.The validity period of the registration certificate is indefinite
2.The circulation of a registered medical device is allowed immediately in all countries in which this registration certificate was agreed (countries of recognition)
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