Nomenclature classification of medical devices by types in Russia

Each medical device registered on the territory of the Russian Federation should belong to a specified type according to nomenclature classification of medical devices. In fact, the nomenclature type of the medical device determines its position among a variety of others and identifies a specific set of medical and technical characteristics (application area, invasiveness, sterility, frequency of use, operational and design peculiarities) that are common for the device.

Nomenclature classification of medical devices by types is practically used in the following cases:

The type code is a unique identification record in the nomenclature classification represented by a six-unit number. The numeric type code is formed as follows: the empty initial code has a value of 100000 and the value increases for 10 for each following record. As an example, let’s consider the first three codes of the nomenclature classification in the table.

As we can see from the table and the picture (given below), for each type code, there are also «Section», «Name», «Description». Let’s review the meaning of each category.

The category «Section» introduces the groups/subgroups of the medical devices to which the devices with this type code belong.

The category «Name» introduces the specified name of the type code. It determines the type or a type group, not a certain device. I.e. it describes a group of devices with the same or similar purpose and arrangement (design). For example, automatic blood analyser.

Categories and classification criteria that describe the medical device type

The category «Description» of the medical device type includes several classification criteria of the medical device type, such as the following:

Let’s take information and classification criteria for the devices with type code 367580 as an example:

— Classification’s section:

2. Auxiliary and general clinical medical devices
2.56. Other auxiliary and general clinical medical devices

— Name of the medical device type:

Face mask for protection of breathing ways, for single use

— Description of the medical device type:

Non-sterile filtering mask that covers nose and mouth of a human, designed for limitation of expansion of infection agents by air-born transmission in course of situations that can be hazardous for population health (for example, influenza pandemic). It usually consists of several layers of non-fabric polymeric materials that do not interfere regular breathing, or fabric/mull. As a rule, it is fixed to the head with use of elastic bands or ties. It is the device for single use.

The help source of the Federal Service of Surveillance in Healthcare «Nomenclature classification of medical devices by type» is available through the link.

You can find information with use of the nomenclature classifier of the Service as follows:

Appearance of the help source of the Federal Service for Surveillance in Healthcare with extended search fields

Algorithm of search for one or another information by the nomenclature classifier is easily understandable with use of the examples of certain situation that are quite common in real practice.

Situation: You need to find the type code for the certain medical device, for example, the automatic blood analyzer.

Search is available by several fields of the Service:

— by the «Name» of the device (enter the full or the partial name in the field of the main search line);

For our example, we can enter the word «Analyzer» in the field; there will be 219 notes in the search results. We view them one by one to find the corresponding code. If we enter «Blood analyzer» in the field, we’ll get only 2 notes with the following difference: the first code denotes automatic analyzer, and the second one denotes the semiautomatic analyzer. We should choose the required code: 130690.

Search results for key word «Analyzer»

Search by the name is not always effective as you can know a wrong term that does not describe one or another device in the classifier list. Thus, some manufacturers can use names «Analysis system», «Blood test system», etc. instead of the term «Analyzer».

The extended search is designed for these very cases. We’ll review its algorithms in the following situations.

Search by the name is not always effective as you can know a wrong term that does not describe one or another device in the classifier list. Thus, some manufacturers can use names «Analysis system», «Blood test system», etc. instead of the term «Analyzer».

The extended search is designed for these very cases. We’ll review its algorithms in the following situations.

Situation: You need to find the type code for the certain medical device and the preliminary search by name gave no results (for example, because our «Analyzer» has the name «Blood analysis system»).

In this case, we should be guided by the fact that we know the matter of use of our device: counting of blood cells (for example, erythrocytes, leucocytes, thrombocytes). Thus, we have a set of key words for extended search in line «Description». To do this, we should enter the words «erythrocyte», «leucocyte», «thrombocyte» one by one. As you can see, we intentionally enter these words in subjective case for the search results to be shown for all the cases (for these words, they are formed by adding of a termination). You can also enter a part of the word.

Among the extended search results, we can find the required code – 130690. However, the results of the extended search by the above-mentioned words gives us several hundred codes. That’s why we can limit our search by section 5 «Medical devices for in vitro diagnostics (IVD)» (our device belongs to the devices for in vitro diagnostics). To use this restriction, we should, during selection of criteria for extended search, fulfill not only the line «Description» but also enter number «5» into the line «Section» that will limit the search process by the mentioned section.

Results of search by Description with limitation by the Section of the classifier list

Thus, we can significantly restrict the number of search results and find the required code easily.

Situation: We have the type code and need to find the classification criteria of this medical device type code.

To do this, enter the known code in the extended search line «Code» and get the required result.

The initial try to use nomenclature classification in practice has been established in the Order of the Ministry of Healthcare of Russia No.4н dated 06.06.2012. Annex No.1 to this Order described the structure of nomenclature classification of medical devices by type. However, the Ministry has failed to implement it in wide practice.

The background cause for development of nomenclature classification in its current form is that the Russian Federation joint to the number of members of the IMDRF (the International Medical Device Regulators Forum) in 2013. This step is intended first for improvement of national law and regulation database with regards to harmonizing of the Russian and the international laws.

In the international law and in the world practice, the great importance characterizes the Global Medical Device Nomenclature (GMDN). The developer of the Global nomenclature is the independent body called GMDN Agency that locates in the Great Britain. That’s why the 26th of May, 2014, the GMDN Agency and the Federal Service for Surveillance in Healthcare has signed up the agreement on assignment of the access right and the procedure of use of the Global nomenclature of medical devices.

The result is the national nomenclature developed on the basis of the Global one, localized according to the Russian laws that regulate trade of medical devices, and the portal of the Federal Service for Surveillance in Healthcare uses this database for its work.

Currently, according to the Resolution of the Government of the Russian Federation No.633 dated 31.05.2018 г, the type code is no more marked in the blank of the registration certificate. However, it should be provided and kept in the registration note of the medical device.

When the type of the medical device changes in the course of formation and actualizing of nomenclature classification of medical devices by types, the Federal Service for Surveillance in Healthcare adds the corresponding changes to the registration note of the state register of medical devices and organizations (individual entrepreneurs) that produce and manufacture medical devices and informs the legal body or the individual entrepreneur for which name the registration certificate for the medical device with changed type has been issued (within 20 working days since the date when the changes have been added to the registration note of the state register).

The reason for this is that the nomenclature classifier is a dynamic system that is constantly subject for changes and clarifying that, as a result, can lead to replacement of initially provided code of the medical device type.

We need to note that correct determination of the type code of the medical device is very important from the point of view of further procedure of state registration of the medical device. That’s why, if you have any concerns about the correctness of the corresponding code selection, address to our experts that will help you to solve these concerns, as well as to answer a number of questions regarding the trade of medical devices.