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Labelling & IFU Requirements

Roszdravnadzor · MOH Order No. 11 · Decree No. 1684 (effective March 2025)

Language Requirement​

All labelling and Instructions for Use (IFU) for medical devices placed on the Russian market must be in Russian using Cyrillic script. This is a strict requirement:

  • Devices with labelling only in English or another foreign language cannot be legally placed on the market
  • Latin transliteration of Russian terms is not acceptable
  • Brand names or trademarks may appear in Latin characters alongside the Russian text, but all mandatory regulatory information must be in Russian Cyrillic

For foreign manufacturers, Russian-language labelling and IFU must be prepared by a certified translator and verified for regulatory compliance before dossier submission. It is strongly recommended to have your RUS REP review labelling during dossier preparation to avoid rejection.

Required Information on the Label​

Russian labelling requirements under MOH Order No. 11 and Decree No. 1684 require the following on device labels:

FieldRequirement
Device nameTrade name and/or common name
ManufacturerName and address of the manufacturer
RUS REPName and address of the Russian Authorized Representative
Classification classDevice risk class (I, IIa, IIb, III)
Lot/serial/model numberBatch number, serial number, or model number as applicable
DatesManufacturing date and/or expiry date
SterilisationMethod of sterilisation for sterile devices
Storage conditionsTemperature range, humidity, light exposure requirements
IFU referenceReference to IFU or abbreviated IFU on label
WarningsContraindications and warnings relevant to safe use
Registration numberState Registration Certificate number

Special Requirements for IVD Devices​

For In Vitro Diagnostic (IVD) devices, labelling must additionally include:

  • Performance parameters and test methodology
  • Analytical and clinical performance characteristics
  • Instructions for proper specimen collection and handling
  • Reference intervals or interpretation guidelines

Refer to GOST R 51088-2013 for detailed IVD labelling requirements.

Abbreviated IFU​

Where label space is limited (e.g. on small devices or packaging), an abbreviated IFU referencing the full instructions may be acceptable if:

  • The label clearly directs users to the full IFU
  • All essential safety warnings and contraindications are included on the label itself
  • The full IFU in Russian is provided with the device or packaging

Confirm with Roszdravnadzor whether your device qualifies for abbreviated labelling during dossier preparation.

EAC Mark (EAEU Devices)​

Devices registered under the EAEU pathway must bear the EAC mark on the label and packaging. The EAC mark (Евразийское Соответствие — Eurasian Conformity) signifies conformity with EAEU technical regulations and is analogous to the CE mark in Europe. National (Russia-only) registrations do not require the EAC mark.

Chestny ZNAK Digital Marking​

From September 2023, Russia has been implementing mandatory digital marking (Data Matrix codes) for specified categories of medical devices under the Chestny ZNAK (Honest Sign) system. This is a serialisation and traceability requirement separate from standard labelling. See Digital Marking — Chestny ZNAK for details.

IFU Requirements​

Full Instructions for Use must be in Russian and must cover:

  • Intended purpose and indications for use
  • Contraindications
  • Operating instructions and precautions
  • Maintenance and cleaning instructions
  • Expected service life or shelf life
  • Warnings about known risks and side effects

Advertising Rules​

Advertising of medical devices in Russia must comply with Federal Law No. 38-FZ "On Advertising." Key requirements:

  • Claims must not be misleading
  • Claims must align with the registered intended purpose
  • Advertising of prescription devices is restricted to specialist publications
Official source

MOH Order No. 11 and Decree No. 1684: minzdrav.gov.ru