Skip to main content

Registration Dossier Requirements

Governing documents​

The registration dossier for a national registration must comply with:

  • Government Decree No. 1684 (2025) — sets out the overall registration rules and dossier requirements
  • MOH Order No. 11 — specifies the detailed technical and user documentation requirements
  • MOH Order No. 4n — classification requirements

For EAEU registration, the dossier must comply with EEC Decision No. 46.

Core dossier contents​

Administrative documents​

  • Application form
  • Power of Attorney with Apostille (from foreign manufacturer to Russian Authorized Representative — mandatory for foreign companies)
  • Proof of payment of state fee

Technical documentation (MOH Order No. 11)​

  • Product description and technical specifications (including functional components, drawings, and diagrams)
  • Intended purpose and indications for use
  • Contraindications and warnings
  • Description of accessories, consumables, and ancillary items
  • Software description (if applicable)

Risk management​

  • Risk management file in accordance with GOST R ISO 14971

Quality and manufacturing​

  • ISO 13485:2016 Certificate (mandatory for Class IIa sterile, IIb, III)
  • Manufacturing process description
  • For Class IIa sterile, IIb, III: evidence of QMS inspection completion (mandatory from 1 January 2024)

Pre-clinical and clinical data​

  • Pre-clinical test reports (safety and performance testing)
  • Clinical evaluation report or clinical investigation data
  • For IVDs: analytical and clinical performance data per GOST R 51088-2013

Labelling​

  • Sample labelling in Russian (mandatory language)
  • Instructions for use (IFU) in Russian

Translation requirements​

All documents submitted to Roszdravnadzor must be in Russian. Foreign documents must be:

  1. Translated into Russian by a certified translator
  2. Where issued in a foreign country: certified with an Apostille stamp in accordance with the Hague Convention
warning

Missing translations or incorrectly certified documents are a common cause of Phase 1 rejection. Ensure all documents are translated before submission.

Document checklist (summary)​

DocumentRequired
Power of Attorney + ApostilleAll foreign manufacturers
Technical documentation (MOH Order No. 11)All classes
ISO 13485 CertificateIIa sterile, IIb, III
QMS inspection certificateIIa sterile, IIb, III (from Jan 2024)
Risk management file (GOST R ISO 14971)All classes
Clinical evaluation / investigation dataAll classes (extent varies)
Russian-language labelling & IFUAll classes
Pre-clinical test reportsAll classes
Official sources

Government Decree No. 1684: government.ru
MOH Order No. 11: minzdrav.gov.ru