Three Things You Should Know about Medical Device Regulations in Russia, November 2019


Dear Colleagues,

There have been no major changes in the regulatory landscape of Russian and Eurasian medical devices for the past month, but  this is my usual newsletter with several short updates which  are good to know if you are interested in medical devices regulation in this region:

1. Updates in Medical Device Control Procedures in Russia

In November several new updates were introduced to strengthen control procedures for medical devices and pharmaceuticals in circulation on the market from Russian healthcare regulators.

On 9 November 2019, the Russian government published Regulation No. 1433 (link in Russian), amending some aspects of the procedure for the inspection of medical devices manufacturers and distributors. According to the published document, within three months, the Ministry of Health is developing a risk indicators  i.e. parameters deviations from which might indicate a likelihood of violations of mandatory requirements for the circulation of medical devices, which are intended to be used for unscheduled inspections.

Under Regulation No. 1459 published on 15 November 2019 (link in Russian), Russian healthcare regulator Roszdravnadzor is empowered to conduct test purchases of medical devices and medicines to verify compliance with regulations, i.e. to check on the sale of falsified, poor-quality and non-registered products.

It should be noted that according to the current regulation, inspections of the medical device manufacturers and distributors are carried out in accordance with the annual plan published by Roszdravnadzor. In limited cases, unplanned inspections may be conducted. Strengthening control of the medical devices on the market is a trend that has been evident in Russia over the last several years.

2. Development of Medical Software Regulation in Russia
In November 2019, the Russian Ministry of Health announced the start of work on the implementation of changes to the classification of the software as a medical device. According to the regulator, improvements should be made following the IMDRF guidelines.

As of today, the medical software is within scope of the Russian definition of a medical device, and some years ago Roszdravnadzor clarified the requirement for its mandatory registration, but to date, no specific guidelines are available in the Russian regulations on medical devices.

3. Simplified Approval Path for Refurbished Medical Devices in Belarus

On 16 November the Belarusian Ministry of Health clarified procedures for obtaining import permits for Belarus in the re-used and refurbished medical devices received as foreign donations. The published letter ( link in Russian) sets out a simplified approval process for refurbished medical devices and rehabilitation equipment of I-Class, on the condition that their residual life is not less than one year.


Thank you for following my blog, which is a non-commercial project with the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. Let me remind you that you can receive my regular updates directly from your email via the ‘follow’ button on the toolbar of this blog.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2019

Dear colleagues,

This is a selection of the latest updates in medical device regulation across Russia and the Eurasian Union countries for January 2019.

  1. Eurasian regulations on quality management inspections

The regulation 106 with requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure came into force in March 2018. However, until today the list of organisations conducting these inspections have not been officially published. At the beginning of 2019, we can see the development in the regulations on this subject.

Thus, on 11 January 2019, the Eurasian Economic Commission (EEC) published a draft document ‘on the requirements for inspecting organisations with the authority to inspect manufacturers of medical devices’ (link in Russian).

Later, on 28 January 2018, two potential organisations appeared on this list: the Russian Ministry of Health published a draft document (link in Russian) suggesting that two Russian governmental bodies, Roszdravnadzor and Rosatom, perform QMS inspections of medical device manufacturers according to the EAEU requirements.

It should be also recalled that abovementioned regulation #106 set the end of the transition period and start of QMS inspections for the EAEU medical approval process as of March 2019.

  1. Some updates in local registration procedures for Russia and Belarus:

There were also some updates for local medical device regulation systems:

On 26 December 2018, the Russian medical device regulator Roszdravnadzor published ‘Methodological recommendations on the procedure for conducting an examination of the quality, efficacy and safety of medical products for state registration’ (link in Russian), approved by both expert organisations involved in the medical registration process. The document may be useful in understanding detailed requirements, national standards and templates of forms used for every step of the medical device examination process during registration in Russia.

Also, on 11 January 2019, the Ministry of Health of Belarus published a letter (link in Russian) clarifying timelines for the different steps of the medical device registration process, inspections and expertise in Belarus.

  1. Changes in tax regulations for medical devices in Russia and Kazakhstan 

On 19 January 2019, according to the law of the Republic of Kazakhstan №211, amendments to the tax code of Kazakhstan came into force, which exempted pharmaceutical products and medical devices from value added tax (VAT). In particular, medical devices, orthopaedic products and hearing equipment, as well as materials and components for their manufacture, are exempt from VAT according to the additionally approved list.

In parallel, on 17 January 2019, the Russian government published the draft regulation (list in Russian) on changes in the list of medical products (Resolution #1042) exempted from VAT. Compared to the current version, the new edition of the list is supplemented with multiple new medical devices classified with Russian OKPD-2 codes.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, March 2017.


Dear Colleagues and Group Members,

Welcome to my monthly update on the latest news on medical device regulations in Russia and the Eurasian Economic Union. Here are three of the most important updates for March 2017:


  1. Russia Released Requirements on Technical Files and Instructions for Use of Medical Devices


On 15th March 2017, the Russian Ministry of Health released Order #11N (link in Russian) with a list of requirements for technical files and instructions for use of medical and in-vitro devices (IVD). Undoubtedly, this is one of the most important and long-awaited Orders concerning medical device regulations issued in Russia in the last few years. Since the Russian medical device regulation system changed in 2013, information on the structure of technical documentation was available only as recommendations or voluntary standards, which could be interpreted differently by different institutions. This was one of the most common sources of a lack of understanding of registration requirements and subsequent registration delays.


The new requirements became effective from 24th March 2017. Since this date, manufacturers have had to ensure that technical files in registration dossiers for medical devices contain 20 mandatory clauses/chapters (and seven additional clauses for IVD products). Meanwhile the structure of so-called “operational documentation” (i.e. instructions for use (IFU) /product inserts/user manuals) must contain 21 clauses/chapters for all medical devices, with 19 additional clauses for IVD products.


As this regulation is relatively recent and no additional guidance has been published, it is difficult to assess the impact at this stage, but it should be noted that some requirements are quite new, for example, one of the requirements for IFU is to provide “the list of data, keys, passwords, and software necessary to mount, set up, operate, and maintain the medical device provided by the manufacturer” (see clause 11g) or to include “the list of national <i.e. Russian?> standards applied by the manufacturer” (see clause 11h).


I will closely follow the development of this topic in my blog and publish an analysis of new requirements relating to any additional guidance in future posts of this blog.




  1. Consulting on Russian Medical Device Registration Procedure


Following Resolution #160 published last month which (among other initiatives) provided the possibility of official consultations on the medical device registration process on behalf of Russian regulatory expert centres, in March 2017 Roszdravnadzor (the Russian medical device regulator) published the draft regulation with a detailed description of the future consultation procedure. According to the document, consultancy will be performed by two Russian expert organisations involved in the registration process, namely VNIIMT (ВНИИМТ) and CMKEE(ЦМИКЭЭ). Consultations could cover registration and re-registration procedures, question classification of medical devices according to Russian regulations and could be carried out by answering questions posed by applicants, both in oral and written forms.

During consultations, experts cannot perform preliminary assessments of a dossier and cannot cover questions regarding expert evaluation.
A consultancy meeting should be scheduled based on the contract between an applicant and expert centre, and should occur within thirty days of receipt of the applicant`s request for a meeting.

The cost of consulting services and their schedules will be determined by each expert centre.




  1. Reporting Adverse Events in Belarus


In March 2017, the Belorussian Ministry of Health clarified its requirements for reporting adverse events for manufacturers of medical devices. According to a letter released on 17th March 2017, the following information must be reported: “serious or unexpected side-effects not mentioned in the instructions for use <of a medical device>, all adverse events during its usage/exploitation, peculiarities of interaction with other medical devices” to include facts of substandard quality and circumstances creating a threat to life and health of patients and medical personnel”. In the same letter, the regulator provided a form for manufacturers or distributors to use for reporting events and warned about responsibility measures in case of potential violations.




My blog is a non-commercial project aimed to make Russian and Eurasian medical device regulations clearer. I would like to remind that you can get my updates directly via e-mail by using the “Follow” button on the toolbar of this page.

Five Questions on Eurasian Medical Device Integration on the Annual National Regulatory Conference

FMO 20151019Less than two months remain until the enforcement of the Agreement on common principles and rules of the circulation of medical products of the Eurasian Economic Union. A special session of the Annual National Regulatory Conference, FarmMedObrashenie, was devoted to this topic on 19 October 2015, where a representative from the Eurasian Economic Commission made a report on the status of second-level regulations to this agreement. It was reported that no final regulations have yet been published and all documents (thirteen in total) are currently still in ‘a high state of readiness’. All drafts are available online. Possible changes ‘will be of an administrative nature’ only and the final regulations are stated to be enforced ‘in very similar editions’.

Representatives from Roszdravnadzor (Russian medical device regulator) expect that ‘in order to avoid a repetition of the painful Russian experience of 2013’, with high probability during the transitional period imposed in chapter 11 of the Agreement, it will be possible to work on two parallel procedures: the local registration procedure of the country (effective today) and a new procedure of the Eurasian Union.

Here there are five questions on Eurasian medical device integration answered by Roszdravnadzor.

Question: If a medical device is registered in Russia today, will it be approved for whole Eurasian Economic Union after 1 January 2015?
Answer: No. All medical devices approved in member states according to local procedures remain approved only in the country of registration. For approval in the whole of the Eurasian Economic Union, medical devices must pass through the new EEU registration procedure.

Question: A registration file will be submitted 31 December 2015. Using which procedure will the medical device be registered?
Answer: In this case, the medical device will be registered under the local registration procedure of the member state.

Question: During the transition period, will the applicant have a right to choose which procedure to use (the new EEU procedure or the old local procedure)?
Answer: Yes, during this period it is now expected that the applicant will able to choose between the procedures.

Question: Will a medical device require the new EAC-med symbol for the EEU after 1 January 2016?
Answer: The new EAC-med symbol will be required for medical devices approved under the new EEU registration process. Medical devices approved under local procedures of member states do not need the EAC-med symbol.

Question: As was previously required, all Russian registration certificates must be replaced by 2017. Will enforcement of the new EEU regulations cancel this requirement?
Answer: No, all Russian registrations with unlimited validity issued before 2013 must be replaced by 1 January 2017 under a special administrative procedure. Roszdravnadzor will continue these replacements in 2016.

Этот пост по-русски

ФармМедОбращение: Пять вопросов об обращении медицинских изделий в Евразийском Cоюзе

FMO 20151019

You can read the English version of this post

Менее трех месяцев остается до вступления в силу  Соглашения о единых принципах и правилах обращения медицинских изделий Евразийского Экономического Союза.  В рамках конференции ФармМедОбращение 19 октября состоялась специальная сессия, посвященная этому событию.

Представителем Евразийской экономической комиссии был сделан доклад о статусе нормативных документов второго уровня к подписанному Соглашению. В докладе сообщалось, что на сегодняшний день все документы (всего 13 нормативных актов) по-прежнему находятся в разных стадиях разработки и согласования.  Было отмечено, что документы «находятся в высокой степени готовности» однако  на сегодняшний день Комиссией не принято ни одного готового документа. Отмечено также,  что возможные правки в проекты разрабатываемых документов «будут носить административный характер», и документы будут «приняты в очень похожих редакциях».

Представителями Росздравнадзора было высказано мнение, что с высокой долей вероятности в переходный период, предусмотренный в гл.11 Соглашения,  будет возможна работа по двум параллельным процедурам: локальной процедуре регистрации страны (то есть процедуре регистрации, действующей на сегодняшний день) и новой процедуре регистрации Евразийского союза, что позволит “избежать повторения болезненного российского опыта 2013 года”.
Сроком действия «локальных» разрешительных документов по-прежнему остается 31 декабря 2021 года.

Очередными ориентирами для возможной готовности части документов была обозначена конференция «Медицина и качество» в начале декабря 2015 года.

Ниже я хотел бы привести ответы на 5 вопросов, заданных из зала на эту тему:

  1. Медицинское изделие зарегистрировано сегодня в России. Возможно ли его обращение в странах Евразийского союза после 01 января 2016 года?
    Ответ: Нет. Медицинские изделия, зарегистрированные в странах Союза по локальным процедурам, останутся разрешенными к применению только в стране регистрации. Для разрешения обращения в рамках Союза необходима регистрация по новой процедуре.
  2. Досье будет подано на регистрацию 31 декабря 2015 года. По какой процедуре пойдет регистрация?
    Ответ: В этом случае регистрация пойдет по локальной процедуре страны.
  3. Во время переходного периода будет ли у заявителя возможность выбора, по какой процедуре подавать заявление?
    Ответ: Да, во время переходного периода у заявителя предполагается возможность выбора между локальной процедурой страны и новой «гармонизированной» процедурой союза.
  4. Требуется ли маркировка новым знаком обращения медицинских изделий с 01 января 2016?
    Ответ: Маркировка новым знаком обращения предполагается для медицинских изделий, разрешенных по новой процедуре Евразийского союза. Для медицинских изделий, зарегистрированных до 01 января 2016 года, новый знак обращения не наносится.
  5. Отменяет ли вступление в силу общих правил обращения медицинских изделий требование к замене бессрочных российских регистрационных удостоверений «старого образца»?Ответ:  Нет, бессрочные регистрационные удостоверения, выданные до 01 января 2013 года, необходимо заменить на новые до 01 января 2017 года.

Обзор проекта правил проведения мониторинга безопасности, качества и эффективности медицинских изделий Евразийского Экономического Союза

English version of this post is coming soon

Как известно, на сегодняшний день мониторинг безопасности медицинских изделий в России, Беларуси и Казахстане регулируется разными законодательными актами.  В августе 2015 года был опубликован проект единых правил, направленных на унификацию требований к мониторингу безопасности медицинских изделий в рамках Евразийского Экономического Союза (ЕЭС). Проект гармонизирован с руководствами  IMDRF (Международный форум регуляторов медицинских изделий) и является документом «второго уровня», дополняющим Соглашение о единых принципах и правилах обращения медицинских изделий. Ожидается, что документ вступит в силу  1 января 2016 года.

В этом посте я хотел бы резюмировать основные практические аспекты документа.


  • О неблагоприятных событиях. Неблагоприятным событием считается  любая неисправность и (или) ухудшение характеристик или нарушение функционирования медицинского изделия, или недостаточность или некорректность сопроводительной информации (документации) на медицинское изделие, или побочное действие, не указанное в инструкции по применению, которые прямо или косвенно привели или могли привести к смерти или серьезному ухудшению состояния здоровья пользователя или другого лица.
  • О корректирующих действиях: в виде первоначального, (и при необходимости)  последующего и заключительного отчетов для уполномоченного органа.
  • По результатам корректирующих действий по безопасности медицинского изделия производитель обязан выпустить уведомление по безопасности медицинского изделия для пользователей.

Проект новых правил рекомендует сообщать  обо всех инцидентах немедленно, при этом устанавливает максимальные сроки для репортирования от двух до тридцати дней в зависимости от серьезности произошедшего неблагоприятного события (см.п.3)

Первоначальный отчет о корректирующих действиях должен быть направлен в уполномоченный орган в сроки, согласованные с уполномоченным органом, в наиболее серьезных случаях -не позднее, чем через два календарных дня после того, как производитель выполнил корректирующие действия.

Согласно проекту новых правил, для неблагоприятных событий, произошедших на территории государства EЭС,  Производитель или его уполномоченный представитель обязаны направлять отчет о неблагоприятном событии,  отчет  корректирующих действиях и выпустить уведомление по безопасности медицинского изделия для пользователей. ( см. п.3)

В отношении инцидентов, произошедших с медицинскими изделиями, зарегистрированными в ЕЭС, на территории других государств, производитель должен направить в уполномоченный орган уведомления по безопасности для  последующего размещения в  информационной базе (см. п.12).

Нововведением для всех стран является предложенный проектом пострегистрационный клинический мониторинг для изделий высокого (IIB, III)  класса риска. Предполагается, что в течение трех лет после государственной регистрации производитель или уполномоченный представитель будут обязаны ежегодно направлять в уполномоченный орган отчеты по клиническому мониторингу (см. приложение 4) , план мониторинга является частью клинического обзора в составе регистрационного досье.  По завершению этого периода уполномоченный орган сможет принять решение о завершении или продлении мониторинга, а также об  отзыве регистрационного удостоверения и  изъятии медицинского изделия из обращения.

За нарушение новых правил установлена достаточно строгая ответственность. В ряде случаев уполномоченный орган имеет право приостановить действие регистрационного удостоверения: Например, в случае если производителю или его уполномоченному представителю стало известно об инциденте, но он не сообщил о нем; в случае если не был направлен последующий или заключительный отчет об инциденте (см.п.23) или же в случае если  не был представлен в один из отчетов по пострегистрационному клиническому мониторингу (см.п.25) а также же по результатам самого мониторинга (см.п.25).

Данный обзор является моим профессиональным анализом общедоступного документа и не является позицией какого-либо регуляторного органа или организации.

Буду рад дополнениям и комментариям.

Review of new Eurasian Economic Union Medical Device Approval Process.

click here for this post in Russian

After the approval of the Agreement on Common Principles and Rules for Circulation of Medical Devices (link in Russian) in the EEU in December 2014, the new rules of registration of medical devices for the future harmonized system can be called the most important and anticipated legal act among “second level” regulations. At the beginning of July 2015 the draft of new registration rules was published on the website of the Eurasian Economic Commission.

Here I would like to shortly recap the main innovations of this draft, as well as its most significant differences compared to existing medical device regulatory systems in Russia, Belarus and Kazakhstan which could expect us since January 2016:

  1. Registration acceptance “by default”?

According to the text of the draft, the new rules do not imply a uniform registration throughout the EEU “by default”. At the beginning, the document introduces the concept of “reference state”, a country in which it is assumed the full cycle of medical device registration occurs with the expertise phase and the “acceptance state”, that accepts the results of expertise by the simplified acceptance procedure of 15 business days. According to the draft, a “reference state” and “acceptance state” are selected by the applicant at the beginning of the registration procedure and after registration is fixed on the title of the registration certificate (see Annex 13).
The non-acceptance of the expert opinion of the reference state (see Clause 32) by another state of EEU, according to the draft, could be reason for prohibition of circulation of a medical device in the territory of the individual states of the EEU.
Form the text of the draft it is not clear whether an authorized representative of the manufacturer is required in each country of the EEU, or one across the entire union.

  1. The transitional period

Probably one of the best pieces of news is that according to the draft, at the beginning of 2016, Eurasian regulation changes seem not to be drastic. Clause three of the new rules introduces a transitional period (exact time is not currently specified). According to the project, during this time the registration dossiers can be submitted either in accordance with existing national legislation of the States of EEU or in accordance with the new harmonized registration procedure. Nevertheless it should be noted that in accordance with clause 15 of the agreement on common principles and rules for the treatment of medical devices, current (local) registration certificates of medical devices will be valid until 31 December 2021 at the latest.

  1. New definitions

The draft of new registration rules introduces new definitions for: component parts, modifications, accessories, and consumable materials for medical devices (as well as some other definitions). Up to now these concepts caused a lot of questions during the registration process in Russia, because they were not fixed in regulations.

  1. The procedure for amendment of registration certificate

In Russia today (unlike Belarus or Kazakhstan) there is two separate procedures: amendment in the registration certificate (according to Clause 37 of the current Russian registration rules) and amendments to the registration dossier (according to Clause 55 of the current Russian registration rules). Based on personal experience, such separation of procedures is not always obvious and sometimes causes a lot of additional questions from the medical device manufacturer. The new rules introduce a single procedure for amendments to the registration dossier. The changes, according to the project, can be carried out with or without the issuance of a new registration certificate. The document provides the reasons and pathways for such amendments (see Section IV of the draft).

  1. Classification and nomenclature

According to clause 15 of the new Eurasian rules, “simultaneous submission for registration of several modifications of the medical device belonging to similar types can be grouped in accordance with the medical device nomenclature of the EEU […] the applicant should submit as a single application and a single registration dossier.” It should be recalled that clause two of the previously approved Agreement on Common Principles for the Treatment of Medical Devices requires “harmonization of the nomenclature of medical devices used in the Member States, with the global medical device nomenclature GMDN”. From a practical standpoint, this change may lead to a multiplication of applications for registration (compared to earlier registrations, particularly in Belarus and Kazakhstan). As you probably know, new nomenclature classification of medical devices has recently been adopted and is already working in Russia and Belarus.

  1. Medical device expertise

In contrast to the current regulatory system, the new rules propose one-step expertise of not more than 60 business days. (In comparison, today in Russia and Belarus, the expertise phase of medical devices registration takes place in two stages, with the official time of 15-30 business days and for Kazakhstan, a three-phase expertise, lasting up to 180 days). It’s no secret that in Russia today, the stage of expertise is the most challenging for the registration. Clause 23 of the new rules describes in detail the main steps of the new expertise of medical devices for the registration. In the case of a lack of necessary information, the new rules allow a one-time request for additional materials from the expert organization, with 60 working days for delivery of these materials for the applicant (today the similar timeframe for Russia is 50 working days, and in Kazakhstan, 30 business days). 

  1. Manufacturer inspection

Today, the inspection of the manufacturer is the most difficult stage of the registration of medical devices in Belarus and Kazakhstan, and is used by regulators in a rather limited number of cases. The draft of new rules (see Clause 22) significantly expands the indications for inspections to control the manufacturer’s quality management system, suggesting regulator inspection of the registration of all medical devices of high risk and sterile products of class 2a. Total time for the organization and conduct of such an inspection, according to the project, shall not exceed 90 business days.

  1. Instruction for use and labelling

A new requirement for the medical device system is the approval of the regulator layout packages and instructions for their placement on the official regulator`s website (see Clause 28 and 35). By analogy with current registration rules in Kazakhstan, the new rules allocate a separate step for approval of the labelling of a medical device (see Clause 24): “the expert organization of the reference state within a period not exceeding 30 business days, confirms the correctness of translation of instructions for medical use and external package marking to the national language in accordance with the requirements of the Member States.”

  1. Pre-registration meetings and consultations

Formal pre-registration consultations are an interesting and long-debated innovation. Clause six of the draft of Eurasian registration rules establishes the possibility of prior consultation from the expert organization “on all issues of expertise and registration.” In its conferences and seminars Russian medical device regulator Roszdravnadzor talked in length about this possibility and the lack of legal mechanisms for its implementation. It should be remembered that today any consultations in the framework of the medical device registration procedure or any contact between an applicant and expert organization are officially prohibited in Russia.

  1. Lead-time for registration

The draft of new Eurasian medical device registration rules introduces the following timeframes for the main steps of medical device registration procedure:
• Five business days for formal checking of the registration dossier
• Three days to initiate registration procedure
• 60 business days for the expertise for registration procedure
• 30 business days for expertise for amendment procedure
• 90 business days for the organization of inspections of manufacturing site
• 30 business days to confirm the accuracy of the translation of instructions and markings
• 15 business days for the procedure of acceptance in selected countries of the EEU

The new rules also set out the following timeframes to provide additional materials on additional regulator`s request:

  • 30 business days after the formal cheek of the dossier (step before expertise)
    • 60 business days to the stage of expertise

I would like to remind you that the document published by the Eurasian Economic Commission currently has the status of a draft in the stage of public discussions. New medical device registration rules are expected to come into force across EEU since January 2016.

Disclaimer: Please note that this review is my professional analysis. It is neither an official report, nor official position of any organization or regulatory body.