Medical and in vitro diagnostic devices intended for the Russian market can be registered via two routes:

1. National Registration at Roszdravnadzor – is valid only in Russia.
2. Sovereign Registration (EAEU) – is valid in the member countries of the Eurasian Economic Union (EAEU): Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. It allows marketing in all EAEU member countries, subject to approval.

Transition to the EAEU System: Registration will only be possible through the EAEU system from January 1, 2027, unless extended.

1. National Registration

• Documentation: it includes power of attorney, licence for manufacture in the country of origin, quality management system certificate, free sale certificate and device details. In addition: data on the Authorised Representative, the Manufacturer and, if different, the Production Facility.
• Tests and clinical investigations: in most cases, local tests in accredited laboratories in Russia are required, including biocompatibility and technical tests.
  For Class IIb and III devices, clinical investigations are compulsory, to be performed at authorised centres in Russia, with special exceptions. For Class I and IIa devices, the clinical evaluation is generally based on existing clinical documentation.
• Production site inspection: mandatory for all manufacturers, Russian and foreign. There may be exceptions or simplified procedures depending on the type of device and circumstances.

2. Sovereign Registration (EAEU)

• The applicant chooses a Reference State and at least one involved Member State for the joint evaluation.
• Documentation: in addition to the national registration, the technical file must comply with the specific EAEU requirements.
• Tests and clinical investigations: can be conducted in any EAEU Member State, in accredited laboratories and clinical centres.
• Production site inspection: carried out by the Reference State.

Applicant

The foreign manufacturer is obliged to appoint an Authorised Representative who assumes responsibility for the compliance of the device during its entire life cycle, from registration to post-market surveillance.

• National Registration: must be domiciled in Russia.
• EAEU registration: must be based in one of the EAEU Member States.

Timeframes 

The foreign manufacturer is obliged to appoint an Authorised Representative who assumes responsibility for the compliance of the device during its entire life cycle, from registration to post-market surveillance.

• National Registration: must be domiciled in Russia. 
• EAEU registration: must be based in one of the EAEU Member States.

Validity

Unlimited validity, unless there are regulatory or technical changes to the device.

Documentation Language and Labelling

• National registration: documents and labelling (labels and IFU) in Russian.
• EAEU registration: final documentation in Russian. Labelling (labels and IFU) in Russian and in the official languages of the Member States. Multilingual labels are allowed if legible.

Useful Information

Russian regulation is gradually being harmonised with the requirements set by the Eurasian Economic Union, with Russia playing a key role in the process. Russia is also part of the International Medical Device Regulatory System (IMDRF).