Frequently Asked Questions (FAQ)
Questions about entering the market
-
What is required to start sales of medical device in Russia?
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.
-
Should foreign manufacturer have Russian entity to join Russian market?
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.
-
Are there special regulations for the market entry of medical devices in Russia?
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.
-
How to find out if a medical device is registered?
Registration Certificate (RC) - This is a document confirming that a medical device can be used in the territory of the Russian Federation. The executive authority responsible for monitoring and oversight in the field of healthcare organization and ensuring public health protection is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the process of registering a medical device (MD) can be obtained on the website https://roszdravnadzor.gov.ru/.
On the homepage of the website, we navigate to the "Services" section.
To search for a registered medical device (MD), you should use the service: State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Production and Manufacture of Medical Devices.
In advanced search, you can specify all available information about the medical device to quickly find it.If, after all manipulations, the medical device is not displayed in the registry, then it is not registered in the territory of the Russian Federation and cannot be in circulation as a medical device. -
Roszdravnadzor - how to use authority resource?
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) is a part of the executive branch and carries out control and oversight functions in the field of healthcare organization and ensuring public health protection. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation dated December 27, 2012, No. 1416 "On Approval of the Rules for State Registration of Medical Devices".
When entering the website of Roszdravnadzor https://roszdravnadzor.gov.ru/, we are greeted with areas of activity where information can be obtained. During the registration process, we need the section "Medical Devices".
In this section, you can find:- All up-to-date information on issued and applicable 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" subsection, you can find answers to all questions, as well as a detailed algorithm of actions for completing the procedure of medical device registration.
On the main page of the website, there is a section called "Services."
What information can be obtained in the "Services" section? Let's consider services applicable in the process of medical device registration.
- Nomenclature classification of medical devices by types. This service will assist in formulating the name of the product and its purpose.
- Information on the progress of inquiries from legal/physical entities. In this service, you can track the number of incoming documents from Roszdravnadzor by the number of your outgoing documents. This number is necessary for tracking permits for importation, registration dossiers, informational letters, etc.
Information about 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 either by their name or by the name of the applicant organization.
Automated System "Import of Unregistered Medical Devices" This service is designed to optimize the procedure for providing information on the import of unregistered medical devices, as provided for by the Features of the circulation of medical devices, including the state registration of a series (batch) of medical devices, approved by the Resolution of the Government of the Russian Federation dated April 3, 2020 No. 430.
Information on the progress of consideration of documents submitted for the registration of medical devices. This section will help track all information about the progress of medical device registration by the incoming number from Roszdravnadzor. Information that can be tracked during registration includes:- Date of application acceptance;
- Responsible executor and their contacts;
- Date of registration commencement;
- Date of sending the expertise assignment (1st stage);
- Dates of commencement and completion of clinical trials;
- Date of sending the expertise assignment (2nd stage);
- Requests for materials and information at all stages of registration and their numbers;
- Refusal of medical device registration and its number;
- Registration certificate of the medical device and its number.
The State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Production and Manufacture of Medical Devices. This register contains information about issued registration certificates (registration number and date, validity period, names and addresses of the manufacturer and applicant, etc.). Also, you can view amendments made to registration certificates.
Questions about technical issues
-
Medical device classification in Russia
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 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.
-
How documents translation and legalization process provided?
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).
-
Medical device classification in Russia
-
How to check competitor medical device information in RZN website?
Since March 1, 2022, under the Resolution of the Government of the Russian Federation dated December 27, 2012, No. 1416 "On the Approval of the Rules for State Registration of Medical Devices," the Federal Service for Surveillance in Healthcare (Roszdravnadzor) has begun to provide additional information on registered medical devices (MD), namely photographic images and instructions for use.
To obtain this information for a specific medical device, the following steps are required:
-
The procedure for the import of medical device for purpose of registration in 2023
Questions about customs
-
Changes in government fees during custom clearance of medical device
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/
-
Payments during samples import process
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