Beawire MD regulation

Government fees for changing process – updates

Roszdravnadzor starts to charge a fee for all changing process where conclusion from expert center is required. This means that if manufacturer changes product name or provide modernization of product composition, he should pay:

  1. Government fee for changing process (Roszdravnadzor staff work) – 1500 Russian Rubles;
  2. Government fee for expert conclusion during changing process (depends on product risk class):

-1 risk class – 20 000 Russian Rubles,

-2a risk class – 30 000 Russian Rubles,

-2b risk class -40 000 Russian Rubles,

-3 risk class – 55 000 Russian Rubles.

Official reason  – changes in Federal Law 25-FZ “Amending The Tax code (Part 2) of Russian Federation” from 07.03.2017. These amendments are going to be started from 07.04.2017.

Please be prepared if you are going to provide changes in your current registration certificate (amendments to registration dossier) and keep in mind that it is still impossible to add new model in current registration certificate !