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Labelling & IFU Requirements

Language requirement​

All labelling and Instructions for Use (IFU) for medical devices placed on the Russian market must be in Russian. This is a strict requirement — devices with labelling only in English or another foreign language cannot be legally placed on the market.

For foreign manufacturers, the Russian-language labelling and IFU must be prepared and verified before submission.

Required information on the label​

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

  • Device name (trade name and/or common name)
  • Name and address of the manufacturer
  • Name and address of the Russian Authorized Representative (RUS REP)
  • Classification class
  • Lot/batch number, serial number, or model number as applicable
  • Manufacturing date and/or expiry date
  • Sterilisation method (for sterile devices)
  • Storage and handling conditions
  • Instructions for use reference (or abbreviated IFU on label)
  • Warnings and contraindications relevant to labelling
  • Registration Certificate number

EAC mark (EAEU devices)​

Devices registered under the EAEU pathway must bear the EAC mark on the label and packaging. The EAC mark signifies conformity with EAEU requirements and is analogous to the CE mark in Europe.

IFU requirements​

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

Advertising rules​

Advertising of medical devices in Russia must not be misleading and must comply with Federal Law No. 38-FZ "On Advertising." Claims made in promotional materials must align with the registered intended purpose.

Official source

MOH Order No. 11: minzdrav.gov.ru

Language requirement​

Cyrillic script requirement ​ All labelling and IFU must be in Russian using Cyrillic script. Latin transliteration of Russian terms is not acceptable. Brand names or trademarks may be presented in Latin characters alongside the Russian translation, but all mandatory regulatory information must appear in Russian Cyrillic.

IFU requirements​

Label space constraints and 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.