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calendary February 8, 2022

Changes in Government fees for medical device approvals in Russia

Government fees for initial registration process as medical device consists of:

  1. Government fee for expertise review (depends on risk class, payment for expert center work reviews technical dossier);
  2. Government fee for registration process (for Roszdravnadzor work and actions with registration dossier, certificate):
 Medical device risk class Before 2021 (RUB) From 1st of Jan 2022 (RUB)
1 (expertise) 45 000 72 000
2а (expertise) 65 000 104 000
2b (expertise) 85 000 136 000
3 (expertise) 115 000 184 000
Government fee for registration process (all risk classes) 7 000 11 000

Government fee for amendments in registration dossier or registration certificate has two parts as well:

  1. Government fee for changes in registration dossier – as a payment for expert center work (depends on potential risk class, required if there are changes in technical dossier, not only in registration certificate as a document);
  2. Government fee for amendment process (payment for Roszdravnadzor work) :
Medical device risk class Before 2021 (RUB) From 1st of Jan 2022 (RUB)
1 (expertise) 20 000 32 000
2а (expertise) 30 000 48 000
2b (expertise) 40 000 64 000
3 (expertise) 55 000 104 000
Government fee for registration process (all risk classes) 1 500 2 500

 

References:

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