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Glossary of Key Terms

TermExplanation
Roszdravnadzor / RZNFederal Service for Surveillance in Healthcare — the Russian medical device regulator
MinzdravMinistry of Health of the Russian Federation
FGBUFederal State Budgetary Institution — the expert scientific bodies that review registration dossiers on behalf of Roszdravnadzor
GRLSState Register of Medical Devices (Государственный реестр медицинских изделий) — the official database of all registered devices
Registration CertificateThe official document issued by Roszdravnadzor confirming a device is registered and may be placed on the Russian market
RUS REPRussian Authorized Representative — the legally required local representative for foreign manufacturers
EAEUEurasian Economic Union — a customs and regulatory union of Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan
EECEurasian Economic Commission — the regulatory body of the EAEU that issues Decisions including EEC Decision No. 46
EAC markEurasian Conformity mark used on products sold in EAEU markets under the EAEU pathway
OKPD-2All-Russian Classifier of Products by Economic Activity — used in Russia to assign classification codes to medical devices
GOST RRussian national standard (Государственный стандарт) — equivalent to ISO standards, often adopted verbatim
Federal Law 323-FZ"On the Fundamentals of Health Protection of Citizens in the Russian Federation" — primary legal basis for medical devices
Decree No. 1684Government Decree No. 1684 (2025) — current rules for medical device registration (replaced Decree No. 1416)
MOH Order No. 11Ministry of Health Order defining technical and user documentation requirements for registration dossiers
FSCAField Safety Corrective Action — a manufacturer-initiated action to reduce risk from a device already on the market
PMSPost-Market Surveillance — ongoing monitoring of device safety and performance after registration
SaMDSoftware as a Medical Device — standalone software with a medical intended purpose
IVDIn Vitro Diagnostic device — a device for examination of specimens derived from the human body