Russia

• National state registration for medical devices (registration process) in Roszdravnadzor
• Declaration of Conformity (GOST R)
• Declaration of Conformity (CU TR 020\2011).

If manufacturer already has registration certificate:

• changing process (when manufacturer needs to change registration file which already in RZN or change information in registration certificate),
• duplicate receiving (when manufacturer lost hard copy of registration certificate).

EEU Medical — Expected Changes in Approvals Scheme

It is expected from 2017 that EEU approval scheme for medical devices will be started as parallel approval process to national schemes for transition period (expected from 2017 till 2021).

CIS countries

National systems — Ukraine | Kazakhstan | Belarus | Kyrgyzstan for this moment.

Expected changes — EEU Medical — for Russia, Kazakhstan, Belarus, Kyrgyzstan and Armenia.

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©Beawire – July 2016