Registration and Digital Marking of Medical Devices in Russia

Medical Devices in Russia

Anyone wishing to sell products in Russia, whether pharmaceuticals, spirits, or medical devices, must comply with certain regulations and, if necessary, guarantee the traceability of their products. A large-scale track-and-trace project in Russia has been transferring numerous product groups to a track-and-trace system for several years to reduce counterfeit products and illegal trade.

According to a recent study by the National Research University Higher School of Economics (April 2021), 0.67 billion packages of antiseptic and disinfectant products were sold in Russia in 2020. Over 50% of these were traded illegally. For this reason, a pilot project on traceability was also carried out in the medical products sector the following year. Labeling is now mandatory for several products. 

To ensure the safety and authenticity of products such as food supplements, medicine, and shoes, digital marking projects are repeatedly carried out in Russia for various product groups. This involves testing the impact of track-and-trace on the industry, consumers, and how the regulations affect logistics. There was a test phase for medical devices from 15.02.2022 to 31.08.2023. However, only manufacturers of certain product groups were able to take part in the pilot project. These included manufacturers of air disinfectors (plus the corresponding accessories), orthopedic shoes and insoles, hearing aids, CT scanners, and incontinence products.  

Deadlines for mandatory labeling and provision of information

Following the test phase, the marking project was launched with mandatory deadlines for the digital marking of medical devices in Russia. Manufacturers of air purifiers, disinfectants, orthopedic shoes, and insoles have been required to register their products since October 2023. In addition, they are obliged to label at the consumer packaging level and report the placement on the market to the authorities. The obligations to track-and-trace and register in the system in Russia apply not only to manufacturers and importers of medical devices. They also refer to medical institutions as well as wholesale and retail organizations. Accordingly, all those involved in placing medical devices on the market or in sales. 

The following products are currently subject to mandatory labeling (see table for exact dates):

– Air disinfectants and cleaners (including devices, bactericidal systems, and circulators for filtering and cleaning indoor air)

– Orthopedic shoes and corrective elements used for orthopedic shoes (including insoles, half insoles)

– Hearing aids (excluding individual parts and accessories)

– Coronary stents

– Computer tomographs

– Hygiene articles for the treatment of incontinence

1.09.2023Mandatory registration in the labeling system
– of all actors who place medical devices on the market, manufacturers, importers, retailers, etc.
– all medical devices concerned
1.10.2023Manufacturers and importers of products that have already participated in the pilot project are obliged to label their products
– Air purifiers, disinfectants (incl. the respective accessories)
– Orthopedic shoes and insoles
1.03.2024Mandatory labeling for
– Hearing aids (except accessories)
– Coronary stents
– Computer tomographs
– Sanitary and hygiene products for the treatment of incontinence
1.09.2024– Obligation to report returns of medical devices in the system
– Medical devices must be scanned at the time of sale
– Goods purchased online are also affected, the system must be provided with corresponding sales information
1.09.2025Electronic document management becomes mandatory
– for shipping and receiving labeled medical devices
– Information about each product unit must be reported to the system

As soon as the labeling obligation for a product group takes effect, the authority also recommends preparing the following processes and testing them for the codes: 

– Ordering codes

– Attachment to packaging

– Submission of an application report

– Document for entering the marking codes in circulation into the labeling system

– Organization of payments

How do medical devices have to be labeled in Russia? Information for manufacturers and importers

Companies require an extended electronic signature (ECES) to participate in the Honest Mark labeling system. This is issued by the Federal Tax Office (CEP issuing offices). They must then register with Markirovka, the electronic monitoring system. 

An area of 13×13 mm is required to apply the code to the packaging. The 2-D data matrix code must contain the following information: 

1) Product code GTIN with 14 digits;

2) Individual serial number with 13 characters;

3) Verification code (crypto code), which guarantees the originality of the marking code.

Importers must note that unmarked products may no longer be imported into Russia. Therefore, the products must be marked before entering the border.

Competent authorities and standards for the registration of medical devices in Russia

The medical technology industry in Russia is not regulated by national legislation alone but is also governed by the decisions of the Eurasian Economic Union. The Eurasian Agreement on Common Principles and Rules of Circulation of Medical Devices was launched in 2016. It is intended to lead to a harmonized medical device market within the Eurasian Union. The corresponding provisions can be found in Regulation #144 of the Eurasian Commission. There have been two extensions since the regulation came into force. In August 2022, they extended the transition phase until 31.12.2025. Since 2022, it has been possible to carry out test registrations of medical devices.

The competent authority in Moscow, where all medical devices must be registered for approval, is called Roszdravnadzor. This is the central department of the Federal Service for Surveillance in Healthcare and Social Development. It is subordinate to the Ministry of Health, Minzdrav. The Medical Device Registration and Control Department is in turn responsible for the active evaluation of medical devices during the registration process and decides whether a medical device may be sold on the Russian market. This authority is also responsible for changes and adaptations to the products, for example, to re-approve them.

Risk classes and GOST certificates

In Russia, similar to the EU, there is a classification according to product type and risk class. They are defined in more detail in Decree No. 4n Medical Device Nomenclature Classification.

Risk classRisk assessment
Class 1low
Class 2amoderate
Class 2bhigh
Class 3critical

GOST certificates are an important part of product documentation when importing goods. These are standard certificates that relate to the products and their product family. A distinction is made between GOST R, i.e. Russian-specific standards, and GOST ISO, i.e. international standards. The industry standards and technical specifications only apply to specific products and therefore do not apply to all medical devices.

Requirements for the registration of medical devices in Russia

To register in Roszdravnadzor, the following documents and information must be provided for all medical devices, regardless of their risk class (Medical Device Ordinance No. 11):

– Registration form 

– Administrative documentation

– Product description and technical specifications. Description of the functional components, parts, and structure of the medical device, including lists, diagrams, illustrations, or drawings of the functional components

– Description of the raw materials

– Stability and sterility reports 

– Labels and instructions for use

– Description and technical specifications of the primary and secondary packaging

– Information on the manufacturing process

– Reports on functionality

– IEC 60601 certificates (if applicable)

– Biocompatibility studies based on ISO 10993 

– User documentation

– Clinical trial protocol (clinical data will be submitted later)

The registration process: medical devices in Russia 

The registration process for medical devices in Russia is divided into two phases:

In the first phase, Roszdravnadzor checks the documents submitted. It checks whether all the information is complete and whether it meets the documentation standard. Afterwards it is forwarded to the FGBU National Institute of Quality, which also checks the information. It decides whether the medical device is suitable for clinical research. If this is confirmed, the registration process is paused and the medical device company must carry out the clinical research and compile the clinical data. 

In the second phase, the registration process is resumed by making the clinical data available to Roszdravnadzor. These are then forwarded to the FGBU for review. If the FGBU finds the data valid and gives its OK for the corresponding product, the registration is finalized by Roszdravnadzor. The data is stored in the database by the authority and the medical technology company receives the registration certificate.

The current situation for medical devices in the Russian market

Due to the current situation (Russia-Ukraine war), a fast-track registration procedure was set up by the Russian authorities in 2022/23. It is intended to prevent shortages of certain medical devices affected by sanctions against Russia. Depending on the risk class, it should be possible to complete registration within five working days. Bureaucratic and testing requirements have also been simplified. However, fast-track certification is only valid until January 1, 2025 (before the extension on September 1, 2023). Other measures include an export ban for certain medical devices.

Relevant documents for the registration of medical devices:

– Federal Law 323, Article 38

– Decree No. 1416 Medical Device Registration Rules

– Decree No. 4n Medical Device Nomenclature Classification

– Ministerial Ordinance No. 11 Technical and User Documentation Requirements

[Disclaimer] This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: November 2023)

More MedTech News