Frequently Asked Questions (FAQ)

Questions about entering the market

In order to get market authorisation in the Russian Federation for any medical device, a permit is a must, as the laws of Russia prohibit any actions with medical devices on the territory of the country without such permissions.

What kind of permits do you need?

The main permit is a Marketing Authorisation Certificate (MAC) issued by Roszdravnadzor (the Federal Service for Surveillance in Healthcare) (Here is the web site of the Department). Specific monitoring of the circulation of medical devices is prescribed by FZ-323, which is the main legal act governing healthcare in Russia; in accordance with this act, medical devices and products require specific control and monitoring due to their impact on human life and health (one shall consider that healthcare is a zone of high priority and is highly restrictive in many countries). The main document governing the steps, procedure and timeline of marketing authorisation within the national system of the Russian Federation is RF Government Order No. 1416. Roszdravnadzor is the authorised regulatory body responsible for related activities (being considered as a Department of the Ministry of Healthcare of the RF)

What is “circulation of a medical device”? Circulation generally means any actions with the device concerned, including its usage, manufacturing, import to the RF, storage, marketing, customs clearance, disposal, etc. (please refer to FZ-323 and Order No. 1416 for a detailed definition of “circulation”).

Other documents often related to the certification or declaration of medical devices; this may be required depending on the type of device concerned, e. g., electrical devices require a conformity certificate (CS), form TR ТS 020/2011, most implants need form DS GOST R, condoms have to be certified to the related GOST R, in the case of measurement devices the type of measurement device has to be certified, etc.

There is no need to establish a manufacturing company office, representative office or any other entity of whatever property form on the territory of the RF in order to start the preparation of documentation and the marketing authorisation process in Russia.

In order to get the market access certificate in the Russain Federation territory, the manufacturer has to appoint the company acting as the Authorised Representative of said manufacturer in Russian Federation.

Only the company (or entrepreneur) duly registered in the RF may be the Authorised Representative of a foreign manufacturer.

For local manufacturers, there is no need to appoint an Authorised Representative, since the manufacturer is already the legal entity duly registered in the RF, and therefore can represent itself in terms of company interests and responsibilities.

On the territory of Russia, there are special norms and rules for confirming conformity for medical devices - medical devices, as well as, for example, medicines, must have a certificate of state registration, which is issued by a government agency. For medical devices, such a document is called: “Registration Certificate”, which is issued by Roszdravnadzor (full name - Federal Service for Surveillance in Healthcare). Medical devices are also subject to other conformity assessment procedures - for example, permission for (samples) import from Roskomnadzor, various types of declaration, etc. But the process of registering a device as a medical one is the main one, which confirms the use of the device in this capacity and allows the circulation of the device.

Control over the circulation of medical devices is also carried out by Roszdravnadzor. The main laws are Federal Law 323 and Decree 1416.

Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical device (MD) can be obtained on the website https: /roszdravnadzor.gov.ru/.

On the main page of the site, go to the “ Services” section.

To search for a registered MD, you should use the service: State register of medical devices and of organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

Knowledge of what information will help in the basic search?

Name of the medical device;
Registration certificate number;
MD registration date;
Applicant’s name and address;
Manufacturer’s name and address;

The search can be performed either by one parameter or by their combination. To do this, we will use the advanced search.

In an advanced search, you can specify all the available information on the MD to find it quickly.

If after all the manipulations the MD does not appear in the registry, then it is not registered in the territory of Russian Federation and cannot be circulated inside Russian Federation.

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “ On Approval of the Rulesr State Registration of Medical Devices” dated December 27, 2012.

At the entrance to the Roszdravnadzor website https: /roszdravnadzor.gov.ru/, we are greeted by areas of activity for which information can be obtained. During the registration process, we need a section “ Medical devices (Медицинские изделия)”

In this section you can find out:

All relevant information on the issued and applied regulatory documents;
News in the field of registration and circulation of medical devices;
Contacts for communication with representatives of Roszdravnadzor.

By going to the “Applicant (Заявитель)” subsection, you can find answers to all questions, as well as a detailed algorithm of actions for passing the MD registration procedure.

The main page of the site has a section “ Services (Сервисы)”.

What information can be found in the “ Services” section? Let’s consider the services used in the product registration process.

Nomenclature classification of medical devices by type

This service will help in formulating the name of the product and its purpose.

Information on the course of consideration of applications from legal entities/ individuals

In this service, you can track the incoming number from Roszdravnadzor by your outgoing number. This number is required for tracking import permits, registration dossiers, newsletters, etc.

Information on the issued permits for the import of medical devices into the territory of the Russian Federation

In this service, you can view the received permits for the import of medical devices by their name or by the name of the applicant organization.

Automated system “ Import of unregistered medical devices”

This service is intended to optimize the procedure for providing information on the import of unregistered medical devices (MD) provided for by the Features circulation of medical items, including the state registration of a series (batch) of a medical device, approved by the Decision of the Government of the Russian Federation No. 430 of April 3, 2020.

Medical device newsletters

In this service you can view information letters issued by Roszdravnadzor on the following topics: non-compliance with established requirements;

about unregistered medical device; medical device safety; quality of medical devices, etc.

Register of issued permits for clinical evaluation of MD and a list of medical organizations conducting clinical evaluation of MD.

In these services, you can get information about the issued permits for clinical testing, as well as a list of testing laboratories (TL) that can conduct them. Before contacting testing laboratory, it is recommended to check its scope of accreditation through the official Internet resource of the Federal Accreditation Service.

Information about testing laboratories and organizations entitled to conduct tests of medical devices in order to register them within the Eurasian Economic Union.

In these sections, you can get information about TL that have the right to test products for the purpose of registration within the Eurasian Economic Union No. 46 “ On the Rules for the Registration and Examination of the Safety, Quality, and Efficiency of Medical Products” dated February 12, 2016.

Information on the status of consideration of documents submitted for registration of medical devices.

This section will help you track all information about the registration of medical devices by the incoming number from Roszdravnadzor. Information that can be tracked during the registration process:

Date of acceptance of the application;
Responsible executor and his contacts;
Registration start date;
Date of sending the assignment for expertise (1st step);
Dates of the beginning and the end of clinical testing;
Date of sending the assignment for expertise (2nd step);
Requests for materials and information at all stages of registration and its numbers;
Refusal to register the medical device and its number;
Registration Certificate of medical device and its number.

9.State register of medical devices and organizations (sole proprietor) engaged in the production and manufacture of medical devices

This register contains information on the issued registration certificates (number and date of registration, validity period, names and addresses of the manufacturer and applicant, etc.) Also, you can see the changes made to registration certificates.

From 03/01/2022, within the framework of Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “ On approval of the rules for state registration of medical devices”, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) began to post additional information on registered medical devices (MD), namely photographic images and instructions for use.

To obtain this information, for a specific medical device, you need to perform the following steps:

We go to the website of Roszdravnadzor https: /roszdravnadzor.gov.ru/and go to the “ Services” section

We go to the State Register of Medical Devices and Organizations (Individual Entrepreneurs) engaged in the production and manufacture of medical devices.

In the search bar, you need to enter the name or number of the registration certificate (RC) of the medical device.

Also, you can use the advanced search to specify additional information about the medical device, if you do not have information about the name or number of the RС.

After entering all the information, a search is carried out and the results of this search appear on the page

We go to the page of this MD to view the registry entry, which contains links to download the RC, photos and instructions. Click the link to get the required information.

Questions about technical issues

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION, ORDER dated 06 June 2012 No. 4n “ON APPROVAL OF THE NOMENCLATURE CLASSIFICATION OF MEDICAL DEVICES” – review.

Appendix No. 1 to the Order on approval of the nomenclature classification of medical devices contains (please refer to Fig. 1) the numerical notation of the type of related medical device, i.e., a 6-digit unique identification entry code, the name of the medical device and a description of the related medical device.

The type name is not the standardised name of a specific medical device, but rather defines the type or typical group or class of devices with a similar or identical intended use and design (construction).

The description of the medical device type is based on 6 classification indices defining this type, namely, the scope of use, invasive/non-invasive nature, sterility, frequency of usage, specific design features, specific operational features; taken together, they allow the unambiguous classification of the medical device under the existing Nomenclature Classification. The Nomenclature classification of medical devices by type is presented in groups and sub-groups and published on the official Roszdravnadzor Web site http://www.roszdravnadzor.ru, under the “Electronic services” heading.

The name and/or description of the medical device may be changed from time to time, either due to increased detail requirements, or due to the emergence of totally new types of medical devices, resulting in the continuous need to update the Nomenclature Classification. That is why Roszdravnadzor updates the data presented in the Nomenclature Classification of medical devices at least once per month, and the related changes are posted on the official Roszdravnadzor Web site.

Appendix No. 2 to the Order on approval of the Nomenclature Classification contains a risk-based classification of medical devices. There are 4 main classes based on risk:

Class 1: low risk medical devices
Class 2a: moderate risk medical devices
Class 2b: increased risk medical devices
Class 3: high risk medical devices

This classification of medical devices considers their intended use and application conditions, as well as the following criteria:

Length of application/usage,
Invasive/non-invasive nature,
Interaction with the human body,
Power sources,
Interaction with the vital functions of the human body.

It is important to consider that multi-class classification of medical devices is not allowed.

Let us highlight some specific features of medical device classification. So, when a medical device is intended for usage in conjunction with other medical devices, each of them has to be classified separately. However, if the medical device could be potentially classified under several classes, the class with the higher potential risk level has to be chosen as the final one.

When the standalone software (SW) is considered as a medical device, classification shall be performed as follows:

When the SW concerned drives or affects the usage of a specific medical device, the SW has to be classified as per the intended use of the medical device driven (or affected).
When the SW has no relation to the operation of any other medical device, it shall be classified individually according to the rules set forth in this Appendix.

For in vitro diagnostics medical devices, the following risk based classes are assumed:

Class 1: medical devices of low individual and/or low public health risks,
Class 2a: medical devices of moderate individual and/or low public health risks,
Class 2b: medical devices of high individual and/or moderate public health risks,
Class 3: medical devices of high individual and/or high public health risks.

Let us highlight some specific features of an in vitro diagnostics medical device classification based on the potential risk associated with its application.

When the medical device is intended for usage in conjunction with other medical devices, each of them has to be classified separately.
Calibrators and controls having qualitatively and quantitatively defined parameters shall have the same class as medical devices which use those calibrators and controls for QA purposes.
When the software controls the operation or affects the results of the in vitro diagnostics medical device, it shall be classified under the same class as the medical device concerned for in vitro diagnostics.

If I have borderline product, how to be sure that this is medical device?

If I have a borderline product (a “dual-use” product), how can I be sure that it is (or is not) considered as a medical device?

Check the classifier in Decree 4n by type of medical device - if you can find a code that describes the product - this product is a medical device.

Usually, legalization of documents by the manufacturer is required in case of government approval - for the Russian Federation (and not only - acceptance of electronic documents is prohibited) this is mandatory.

What does the legalization process look like when registering a medical device?

First, the manufacturer prepares a document (the type of document depends on the requirements of the government agency in accordance with the list). After this, the manufacturer or company in the country of production (an agent providing such services) begins the legalization process. The type of process depends on the country - it can be the process of affixing an apostille or legalization at the consul (at the Embassy of the Russian Federation).

Thus, after this, the manufacturer has a printed copy - the original legalization document, which he is ready to send to the Russian company conducting the registration process. When the company responsible for state registration in Russia (hereinafter - the “third party”) receives this document - it still cannot be used, since its translation into Russian is missing (consular stamp or apostille, even if the rest of the document already translated during the legalization process). Therefore, the third party needs to translate it into Russian with notarization (the official process for translated documents). After this, a printed copy of the legalization document will look like, for example, the original document with an apostille, with a translation of the entire text (the text of the apostille must also be translated) and with the stamp of a Russian notary.

Only then can the document be used as part of the registration document, as well as a notarized copy of this paper document in case the manufacturer or third party does not provide the original (for example, if the same document will be used to register several devices).

Review of the Order from the Ministry of Healthcare of the Russian Federation dated June 6, 2012, No. 4n "On the Approval of the Nomenclature Classification of Medical Devices"

Appendix No. 1 to the order on the approval of the nomenclature classification of medical devices contains (Figure 1): numerical designation of the type of medical device - a six-digit identification unique number of the record; name of the type of medical device; description of the type of medical device.

Review of the Order from the Ministry of Healthcare of the Russian Federation dated June 6, 2012, No. 4n "On the Approval of the Nomenclature Classification of Medical Devices" — summary

The name of the type is not a standardized name of a specific medical device but defines the type or group of types, which is a set of products with the same or similar purpose and design.

The description of the type of medical device is formed based on 6 classification features for forming the type of medical device: application area, invasiveness, sterility, frequency of use, design features, and operational characteristics, allowing unambiguous classification of the medical device according to the Nomenclature Classification. The nomenclature classification of medical devices by types is formed into groups and subgroups and is placed on the official website of Roszdravnadzor http://www.roszdravnadzor.ru in the section "Electronic Services."

Changes may be made to the name and description of the type of medical device over time, due to increased requirements for detailing a specific type or the emergence of fundamentally new types of medical devices, which requires constant updating of the Nomenclature Classification. In this regard, Roszdravnadzor updates the data of the Nomenclature Classification of medical devices by types no less than once a month, with these changes posted on the official website of Roszdravnadzor.

Appendix No. 2 to the order on the approval of the nomenclature classification of medical devices presents classification depending on the potential risk of use. The main 4 classes are distinguished:

Class 1 — medical devices with low risk; Class 2a — medical devices with moderate risk; Class 2b — medical devices with increased risk; Class 3 — medical devices with high risk.

When classifying medical devices, their functional purpose and conditions of use are taken into account, as well as the following criteria:

Duration of use; Invasiveness; Method of interaction with the human body; Sources of energy; Interaction with vital body functions.

It is important to note that each medical device can only be assigned to one class.

Let's highlight some features of the classification of medical devices. If a medical device is intended for use in combination with other medical devices, classes are established for each medical device. At the same time, when one medical device can be classified into several classes, the class corresponding to the higher degree of potential risk is established.

If standalone software is a medical device, it must be classified as follows:

If the software activates or affects the use of a particular medical device, it should be classified according to the intended use of this medical device; If the software is not related to the operation of any other medical device, it should be classified separately using the rules outlined in this appendix.

When classifying medical devices for in vitro diagnostics, the following classes are distinguished:

Class 1 — medical devices with low individual risk and low risk to public health; Class 2a — medical devices with moderate individual risk and/or low risk to public health; Class 2b — medical devices with high individual risk and/or moderate risk to public health; Class 3 — medical devices with high individual risk and/or high risk to public health.

Let's highlight some features of the classification of medical devices for in vitro diagnostics depending on the degree of potential risk of use:

If a medical device is intended for use in combination with other medical devices, classes are established for each medical device; Calibration and control materials with quantitatively and qualitatively defined values belong to the same class as the medical devices they are intended to control; If software controls or affects the results of an in vitro diagnostic medical device, it is classified in the same class as that in vitro diagnostic medical device.

The Ministry of Health of the Russian Federation, on May 2, 2023, approved the procedure for importing medical devices for the purpose of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices for registration purposes electronically.

The notification procedure for the import of unregistered medical devices for their registration was introduced back in the summer of 2022. Since then, obtaining permission for import from Roszdravnadzor was no longer required (Information Letter No. 04i-879/22 dated 08.08.2022). The simplification of the import procedure was carried out within the framework of the "regulatory guillotine" and Government Resolution No. 336 dated March 10, 2022, which established features of inspections in 2022.

However, up to the present moment, the corresponding changes have not been made to Order No. 661n "On Approval of the Procedure for Importing Medical Devices into the Territory of the Russian Federation for the Purpose of State Registration." Order No. 201n, approved a year later, replaced the previously applicable Order 661n.

To obtain permission to import an unregistered medical device, the applicant must submit a notification signed with an enhanced qualified electronic signature through the government services portal. The Order also specifies the amount of information that must be provided about the medical device and the applicant:

Name of the medical device including model, version, configuration, accessories, quantity, serial number, batch number, date of manufacture, expiration date
Information about the registration certificate (if the notification is submitted as part of making changes)
Information about the purpose of the medical device
Name of the applicant and information about the legal entity
Name of the manufacturer, their address, and the address of the manufacturing site
Information about organizations where testing is planned
Roszdravnadzor notifies the applicant electronically within 1 working day of receiving the notification and maintains a register of accepted notifications.

If additional samples need to be imported, the notification is sent again.

Order 201n comes into force on September 1, 2023, and is valid until September 1, 2029.

Questions about customs

In accordance with the aforementioned decisions, a 0% import duty rate is set for goods from the list until September 30, 2022.

Unfortunately, after September 30, 2022, new import duty rates ranging from 7.5% to 12% will be applied to goods from the list, which is higher than the previous rate. For example:

For goods under HS code 7606 12 920 3 from the group "Aluminum and its products," specifically: "plates, sheets, strips, or foil of aluminum, with a thickness exceeding 0.2 mm rectangular (including square), of aluminum alloys with a tensile strength of not less than 262 MPa, in rolls with a width of not less than 1000 mm, but not more than 2000 mm," the import duty rate will change from 10% to 12% from October 1, 2022, to February 28, 2023, inclusive. This applies to samples of materials for conducting toxicological studies, which are imported separately from the finished medical device.

Please note that VAT is calculated by the formula = (customs value of the goods + duty) * VAT rate. Therefore, the final customs payments for importing aluminum materials will increase both in terms of import duty and VAT.

We also provide you with a list of medical devices included in the above-mentioned decisions and imported with a 0% import duty rate until September 30, 2022. Additionally, please be aware that after the expiration of the decisions, the duty rates will remain unchanged as they were before the implementation of these decisions.

Examples of medical devices included in Decision No. 46 of April 5, 2022.

Decision of the Board of the Eurasian Economic Commission dated April 5, 2022, No. 46 "On Establishing Import Duty Rates of the Unified Customs Tariff of the Eurasian Economic Union for Certain Types of Goods, and Amendments to Some Decisions of the Customs Union Commission and the Board of the Eurasian Economic Commission." https://www.alta.ru/tamdoc/22sr0046

Decision of the Collegium of the Eurasian Economic Commission dated April 12, 2022, No. 63 "On Establishing Import Duty Rates of the Unified Customs Tariff of the Eurasian Economic Union for Certain Types of Goods Imported into the Customs Territory of the Eurasian Economic Union for the Purpose of Ensuring the Economic Stability of the Member States of the Eurasian Economic Union." https://www.alta.ru/tamdoc/22sr0046

Information on commodity code 3006 10 900 0 https://www.alta.ru/tamdoc/22kr0063/

Information on commodity code 3002 12 000 5https://www.alta.ru/tnved/code/3006109000/

Information on commodity code 3002 12 000 9 https://www.alta.ru/tnved/code/3002120005/

Information on commodity code 9402 90 000 0 https://www.alta.ru/tnved/code/3002120009/

Information on commodity code 3006 70 000 0 https://www.alta.ru/tnved/code/9402900000/

Information on commodity code 9018 31 100 9 https://www.alta.ru/tnved/code/3006700000/

Information on commodity code 3006 10 300 9 https://www.alta.ru/tnved/code/9018311009/

Information on commodity code 8544 42 900 7 https://www.alta.ru/tnved/code/3006103009/

Information on commodity code 3212 90 000 0 https://www.alta.ru/tnved/code/8544429007/

Information on commodity code 3822 90 000 0 https://www.alta.ru/tnved/code/3212900000/

Information on commodity code 7318 15 590 0 https://www.alta.ru/tnved/code/3822900000/

Information on commodity code 7326 90 940 9 https://www.alta.ru/tnved/code/7318155900/

Information on commodity code 8544 42 900 7 https://www.alta.ru/tnved/code/7326909409/

1. Customs fees

Customs fees (code in the customs declaration 1010, in this document we consider only the subtype of customs fees “for customs clearance”) - this is a fixed rate for customs clearance, which depends on the declared value of the cargo. The rates are shown in table:

2. Import duty

Import customs duty (ICD) (code in the customs declaration 2010) is a payment collected by customs for the import of goods into the territory of the Russian Federation and other countries of the EAEU. Payment of import duty is mandatory.

The size of the ICD is determined by the HS code [ii] selected by the declarant in accordance with the description of the imported product.

Possible import duty amounts depending on the HS code: 0%, 3%, 5%, 6.5%, 7.5%, 8%, 10%, 12% and 15%.

3. Customs VAT

Customs value added tax (customs VAT) is a payment that is regulated by the legislation of the EAEU and is paid when importing goods into the territory of the Russian Federation. The import of goods into the customs territory of the Russian Federation is recognized as subject to value added tax[iii].

The amount of customs VAT is determined by the OKPD2 code and the HS code applicable to the imported product in accordance with the description of the imported product.

Possible amounts of VAT depending on the HS code: 0% and 10% - if one of the preferential tariffs is applicable if there is a Registration Certificate for a medical device [iv] [v], or 20% in other cases.

Note 1: VAT is usually calculated using the general formula VAT = (Customs Value + Customs Duty + Excise Tax) x VAT Rate.

In the case of medical devices, excise duty is not levied, so the formula for calculating VAT for medical devices (if preferences in the form of exemption from customs payments are not applied) is as follows: VAT = (Customs value + Customs duty) x VAT rate.

Note 2: customs payments depend on the exchange rate, since initially the cost of the cargo and the amount of customs payments are calculated in the currency of the provided invoice. In case of such recalculations, it is made at the official exchange rate of foreign currency to the ruble of the Russian Federation, established by the Central Bank of the Russian Federation and valid on the day of registration of the customs declaration by the customs authority, unless otherwise established by the Code of the Union or this Federal Law[vi].

[i] Decree of the Government of the Russian Federation of November 28, 2024 No. 1637 “On the rates and base for calculating customs fees for customs operations related to the release of goods”

[ii] Decision of the Council of the Eurasian Economic Commission dated July 16, 2012 No. 54 (as amended on November 24, 2020) “On approval of the unified Commodity Nomenclature for Foreign Economic Activity of the Eurasian Economic Union and the Unified Customs Tariff of the Eurasian Economic Union”

[iii] Tax Code of the Russian Federation, Part 2 (Tax Code of the Russian Federation, Part 2), Art. 146, clause 1, sub. 4

[iv] Decree of the Government of the Russian Federation of September 15, 2008 No. 688 “On approval of lists of codes of medical products subject to value added tax at a tax rate of 10 percent”

[v] Decree of the Government of the Russian Federation of September 30, 2015 No. 1042 “On approval of the list of medical products, the sale of which on the territory of the Russian Federation and the import of which into the territory of the Russian Federation and other territories under its jurisdiction are not subject to taxation (exempt from taxation) ) value added tax"

[vi] Federal Law of August 3, 2018 No. 289-FZ “On customs regulation in the Russian Federation and on amendments to certain legislative acts of the Russian Federation”, Article 33