Eurasian Economic Union (EAEU) - MedStandard

Eurasian Economic Union (EAEU)

The Eurasian Economic Commission (EEC)

Decision of the Council of the Eurasian Economic Commission dated 12 February 2016 №46

Indefinitely

12–14 months

Russian

resident of a Member State of the Union

A brief algorithm for registration of medical devices within the framework of the Eurasian Economic Union:

01

Collection of documents according to the approved list

02

Determination of application risk class and nomenclature type

03

Gathering evidence of safety and efficacy, tests

04

Selection of reference country and country of recognition (1 or more)

05

Initiation of payment in the reference country

06

Converting the dossier into XML format and sending it to the regulatory authority of the reference country

07

Examination of quality, safety and effectiveness of medical device. Production site inspection.

08

Harmonization of the expert opinion with the country (countries) of recognition

09

Registration certificate issuance

Final price and terms procedures will be calculated according to your request