Registration of medical devices is a complex, long, and expensive procedure. One way to reduce registration costs is to include several medical devices in one registration certificate. The current national (Russian) registration rules allow for this option, and participants of the national (Russian) medical device market continue to use it.

According to the Methodological Recommendations on the procedure for examining the quality, effectiveness and safety of medical devices for state registration, the national (Russian) registration rules allow including devices with different type codes of medical device (according to the nomenclature classification) in one registration certificate, if the included devices comply with the following classification criteria:

  • application area – one cannot combine medical devices for gynecology and ophthalmology, dentistry and general surgery, etc.;
  • invasiveness – invasive products cannot be combined with products that do not penetrate the human body. For example, one cannot combine surface and needle electrodes;
  • sterility – it is prohibited to combine sterile and non-sterile medical devices. For example, clothes (robes, suits, etc.);
  • frequency of use (single or repeated use) – one cannot include in one registration certificate reusable and disposable endoscopic instruments;
  • operational features – one cannot combine devices for intensive care and devices for general wards; or devices intended for professional and home use;
  • design features – it is prohibited to include active (electrical) and non-active medical devices in one registration certificate. For example, mechanical and electric beds.

The procedure allows including a significant number of models (versions) of a medical device in Russia into one registration certificate. For example, it is currently possible to receive a registration certificate for entire groups of surgical instruments: cutting, multi-surface, and pressing ones, which belong to different types in the nomenclature classification. In addition, it is possible to register sets of medical devices with the inclusion of mandatory components and optional items. Thus, national (Russian) registration certificates can include dozens and even hundreds of items, which significantly reduces registration costs for applicants.
However, the opportunity to submit registration dossiers for the national (Russian) registration ends on December 31, 2024. In 2024, only registration according to the EAEU rules will remain possible. These rules impose significant restrictions on the possibility of combining various medical devices into one registration certificate.

Currently, and until 2025, the rules in effect are the Rules for registration and examination of the safety, quality and effectiveness of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46. Following clause 14 of these Rules, it is not allowed to issue one registration certificates for medical devices which belong to various type codes of the nomenclature classification used in the EAEU.

At the same time, registration of medical devices of the same type code in one registration certificate is possible only if there is full compliance with the requirements of the document “Criteria for inclusion in one registration certificate of several modifications of a medical device related to the same type of medical device according to the medical devices nomenclature used in the Eurasian Economic Union” (approved by the Decision of the Board of the Eurasian Economic Commission dated July 24, 2018 No. 123).

This document establishes the following requirements for the inclusion of several modifications of a medical device into one registration certificate:

  • modifications of a medical device are produced by the same manufacturer according to the same technical documentation;
  • modifications of a medical device belong to the same class of potential application risk;
  • intended to determine the presence or the quantitative content of the same clinically (diagnostically) significant analyte in a biological sample (for medical devices for in vitro diagnostics);
  • modifications of a medical device have different component parts that do not affect the operating principle or the functional purpose, but allow expanding or specializing their use for medical purposes (if applicable);
  • modifications of a medical device have different technical parameters (for example, radiation wavelength, light field size, resolution, etc.) that do not affect the operating principle or the functional purpose (if applicable);
  • modifications of a medical device form a standard size range (for example, they have different sizes (dimensional, linear, volumetric, etc.), shapes, color coding, etc.) or are a group of design versions of a medical device (for example, a stationary mobile device (apparatus, system, complex, etc.) with wall and (or) floor mounting, etc.) (if applicable). The group of design versions of a medical device refers to devices which are based on the same group drawing of parts and (or) the same group specification.

Thus, until 2025, applicants can include an extremely limited amount of medical devices in one registration certificate, which makes it financially impractical to register entire groups of medical devices: reusable instruments, sample collectors, prosthetics for implants, prosthetic heart valves (aortic and mitral valves currently have different type codes), etc.

However, starting from 2025, the decision of the Council of the Eurasian Economic Commission “On amendments to the Rules for registration and examination of the safety, quality and effectiveness of medical devices”, approved by the Order of the Board of the Eurasian Economic Commission No. 148 dated September 21, 2021, comes into force. Clause 19 of the amended Rules will allow inclusion into one registration certificate of models (brands) of medical devices that belong to different types according to the medical devices nomenclature used in the Union. Then medical devices included in one registration certificate will have to comply with the following criteria:

  • models (brands) of a medical device are produced by the same manufacturer according to the same technical documentation;
  • models (brands) of a medical device belong to the same class of potential application risk;
  • models (brands) of a medical device have the same functional purpose and operating principle;
  • models (brands) of a medical device are intended to determine the presence and (or) quantitative content of the same clinically (diagnostically) significant analyte (analytes) in a biological sample (for medical devices for in vitro diagnostics);
  • models (brands) of a medical device have different component parts that do not affect the operating principle or the functional purpose, but allow expanding or specializing their use for medical purposes (if applicable);
  • models (brands) of a medical device have different technical parameters (for example, radiation wavelength, light field size, resolution, etc.) that do not affect the operating principle or the functional purpose (as applicable);
  • models (brands) of a medical product form a standard size (model) range (for example, they have different sizes (dimensional, linear, volumetric, etc.), shapes, color coding, are made from the same materials, etc.) or are a group of design versions of a medical device (for example, a stationary mobile device (apparatus, system, complex, etc.) with wall and (or) floor mounting, etc.) (if applicable). The group of design versions of a medical device refers to devices which are based on the same group drawing of parts and (or) the same group specification;

  • models (brands) of a medical device have the same characteristics in terms of:
    – application area;
    – invasiveness;
    – sterility (taking into account sterilization methods);
    – frequency of use (single use, repeated use by one patient, repeated use by several patients);
    – operational and design features;
    – duration of use;
    – similarity of modifications materials which are in contact with the human body (according to their chemical, toxicological, physical, electrical, morphological, and mechanical properties).

The amended Rules impose severe restrictions on the possibility of combining various medical devices into one registration certificate. However, for the first time in a long period, the Rules contain fairly transparent, legally established criteria that can guide you when deciding which devices to include in the registration certificate. Previously, such criteria were established only by the Methodological Recommendations, which were primarily an internal document for Roszdravnadzor and its subordinate organizations.

Summarizing the above, we can make the following conclusions. Applicants registering a medical device without design versions (models, modifications, except for the size range) may not pay attention to the requirements discussed above, since the device will comply with those requirements either way.

For applicants registering several medical devices during one registration, including the devices with different type codes according to nomenclature classifiers, we recommend that they adhere to the following strategy.

Those who plan to apply for registration by the national (Russian) rules should carefully check the list of devices included in one registration certificate since the inclusion in one registration certificate of devices that do not follow the Methodological Recommendations leads to errors and even refusal of registration. Moreover, in case of refusal, it will no longer be possible to re-apply for the national registration and you would have to start registration all over again according to the EAEU rules. Previously conducted laboratory tests will not be applicable in this case.

For those who have already begun registration according to the EAEU rules and are registering devices with the same type code, we recommend continuing registration without waiting for changes to the Rules to come into force – this will allow obtaining a registration certificate as quickly as possible.

For those who postponed the registration process according to the EAEU rules due to the impossibility of combining certain medical devices into one registration certificate, and have been looking for ways to minimize the costs of registration, we recommend starting to prepare registration dossier documents and conducting the necessary tests. By the end of the preparations, the amended Rules will come into effect and you can submit the registration dossier immediately. This will minimize the waiting period for the registration certificate to be issued.

Registration of medical devices according to the EAEU rules is a new, not fully polished procedure. To complete it successfully, one needs up-to-date knowledge, extensive experience, and the ability to find ways out of difficult situations. Our experts meet all the above criteria, which allows us to select the optimal solution for registering medical devices for each of our clients.

We will be happy to help you with registration according to the EAEU rules and answer any of your questions related to the circulation of medical devices.