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Regulatory Framework Overview

The two-layer system​

Russia's medical device regulatory system has two layers:

  1. National system — governed by Russian federal law and Roszdravnadzor. A Registration Certificate under this route is valid only in Russia.
  2. EAEU (Eurasian Economic Union) system — a harmonised multi-country framework valid across Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. A single EAEU Registration Certificate gives access to all five markets.
EAEU transition deadline

From 1 January 2027, Roszdravnadzor will only accept new registration submissions under the EAEU pathway. Manufacturers entering the Russian market for the first time should plan to register under EAEU rules. Existing national registrations remain valid until expiry but cannot be renewed after the deadline.

Key authorities​

AuthorityRole
Roszdravnadzor (RZN)Federal regulator — receives submissions, grants Registration Certificates, conducts inspections and surveillance
Ministry of Health (Minzdrav)Issues ministerial orders on documentation requirements and classification
FGBU National Institute of QualityScientific expert body — reviews dossiers and issues expert opinions
Two further FGBUsSupport Roszdravnadzor in specialist technical and clinical reviews
EEC (Eurasian Economic Commission)Governs EAEU rules; its Decisions have direct effect across member states

Key legislation​

The primary legal basis for medical devices is Article 38 of Federal Law No. 323-FZ. Below this sits a tiered set of Government Decrees and Ministry of Health Orders:

  • Government Decree No. 1684 (2025) — registration rules (replaced Decree No. 1416 from March 2025)
  • MOH Order No. 11 — technical and user documentation requirements
  • MOH Order No. 4n — classification rules
  • EEC Decision No. 46 — EAEU registration requirements

See the Legislation section for the full picture.

The GRLS — State Register​

Every medical device legally placed on the Russian market must have an entry in the GRLS (Государственный реестр медицинских изделий — State Register of Medical Devices), maintained at grls.rosminzdrav.ru. The GRLS entry contains the device name, manufacturer details, classification class, intended purpose, and certificate validity.

Scope of regulation​

All medical devices — domestic and imported — that are placed on the Russian market must be registered before commercial sale. Foreign manufacturers must appoint a Russian Authorized Representative (RUS REP) who acts as the legal point of contact with Roszdravnadzor.

Official sources