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 In the Russian Federation, all medical devices in order to be placed on the local market must be registered in Moscow, at the Central Department of the Federal Service for Public Health Surveillance (Roszdravnadzor).
The registration process, depending on the risk class, is divided into various phases preceded by the drafting of the technical dossier and execution of the following tests on the representative samples of the MD: biocompatibility and toxicity, electromagnetic compatibility, general safety and clinical evaluation. For innovative MDs that do not have an equivalent already registered in Russia, clinical evaluation is performed in vivo following the authorization of National Ethics Committee. All tests are performed in local laboratories and health facilities.
In addition, from 01/01/2024 for class IIa (sterile), IIb and III medical devices, a manufacturing plant inspection by Russian authorities has been introduced.
Registration is made with reference to a single CND RUS code (National Classification of Medical Devices), a single risk class and supply conditions (sterile vs non-sterile) and may include accessories of the medical device.
The definition of such terms as: medical device, accessory, invasive, non-invasive, active vs inactive MD, etc. and the classification rules in Russia and the countries of the former Soviet Union are harmonized with the EEC Directive 93/42.
For some medical devices with measuring functions (thermometers, scales, analyzers, etc.) in addition to registration with the Health Ministry, pattern approval for the measurement instruments (metrological certificate) is required.
The registration procedures are described below, by way of example and not exhaustively:
- until 01/01/2028 MD class I (non-sterile) pursuant to RUS Govt. Decree No. 552 of 01/04/2022 "MD at risk of shortage on the national territory due to sanctions": fast registration with "credit" certificate.
The certificate is issued within 5 working days from submission of the registration application. The applicant has 6 months to complete the procedure (perform the necessary tests). In case of failure to complete the procedure, the certificate is revoked.
- single-stage registration MD class I: the formal assessment is combined with the substantial one. In case of positive outcome, the certificate is issued in 6-8 months.
- multi-stage registration for the remaining risk classes: first the formal assessment is performed, then the substantial assessment. If the substantial assessment is positive, the clinical assessment is carried out, which ends with a second substantial assessment at the end of which, if the outcome is positive, the registration certificate is issued. This process can have a total duration of up to 2 years.
Registration of medical devices in Russia is characterized by frequent "on-the-fly" change to the existing legislation and requests for additional evidentiary documents.
In the medical device registration certificate the following information is indicated: MD and accessories (if any) description and designation, name of the manufacturer and/or developer and holder of the certificate, risk class, CND RUS code, NACE RUS code, manufacturing plant, details of the approval decree.
 CAUTION!
The correct classification of the medical device in the beginning of the registration process allows you to enjoy total (RUS Govt. Decree No. 1042 of 30/09/2015) or partial (RUS Govt. Decree No. 688 of 15/09/2008) exemption from VAT for essential medial devices.
 Translation of medical device registration certificate (ITA 72 KB)
Summary diagram of the medical device registration process (ITA 72 KB)
Normative References
Registration of medical devices in Russia is regulated by the following regulatory documents:
RUS Govt. Decree No. 1416 of 27/12/2012 (ENG 77 KB) (in force until 01/03/2025)
RUS Govt. Decree No. 1684 of 30/11/2024 (RUS 686 KB) (effective from 01/03/2025)
Guidelines for the medical device testing and clinical evaluation (RUS 2,65 MB)
List of medical devices with measuring functions (RUS 194 KB)
Guidelines for the preparation of registration dossier (RUS 3,3 MB)
Guidelines for medical device classification (RUS 279 KB)
New National Medical Device Nomenclature (effective from 01/2015)
Certificate holder and registration validity period
The medical device registration certificate can be issued to the manufacturer (manufacturer's authorized representative (RUS REP), developer or local dealer and it is valid for an indefinite period.
Required documentation
1) Technical documentation as per Reg. (EU) 2017/745 (Annex II)
2) ISO 13485 certificate (for classes IIa sterile, IIb and III)
3) Power of attorney with Apostille stamp*
4) Medical device samples
N.B.: Additional documents may be be required for each individual case.
*Public documents and certifications issued by European public administrations must be provided with an Apostille stamp.
The power of attorney must be legalized at the civil registry of the Court having jurisdiction over the area.
All the documents must be duly translated into Russian by a certified translator.
Release times and costs
Registration:
- MD class I (non-sterile) pursuant to RUS Govt. Decree No. 552 (sanctions impact): 5 working days
- MD pursuant to RUS Govt. Decree No. 552 (sanctions impact): 30 working days
- MD class I (COVID) pursuant to RUS Govt. Decree No. 1416: 5 working days
- MD (all classes) pursuant to RUS Govt. Decree No. 1416: 50 working days
Registration certificate update:
- administrative updates (holder change following company transformation, change of RUS REP, trademark, etc.): 15 working days
- substantial changes that require re-examination of the registration: up to 3 months
N.B.: The above timeframes are "best case" regulatory timeframes that do not include the time required to prepare the documentation and carry out the various tests and assessments.
State fee for medical device registration in Russia:
Audit of the manufacturing plant for MD class IIa (sterile), IIb and III, max: 3.069.000 RUR (approx. 31.200 EURO)
Certificate issue: 11.000 RUR (approx. 110 EURO)
Certificate update or replacement: 2.500 RUR (approx. 25 EURO)
MD conformity assessment:
Class I: 72.000 RUR (approx. 720 EURO)
Class IIa: 104.000 RUR (approx. 1.040 EURO)
Class IIb: 136.000 RUR (approx. 1.360 EURO)
Class III: 184.000 RUR (approx. 1.840 EURO)
N.B.: To the above mentioned costs must be added the costs of the various tests.
How to check your application status
To check the status of your application (click here)
Enter the number and the date of the submission of application that were communicated to you.
Where and when
Federal Service on Surveillance in Healthcare
Department for Market Surveillance and Registration of Medical Devices
Headquarters: Moscow 109074, Slavjanskaja Square, 4 building 1.
Tel: +7 499 578-06-07 ext. 299,
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Monday - Thursday: 09:00-13:00, 13:45-18:00
Friday: 09:00-13:00, 13:45-16:45
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