Tag Archives: Roszdravnadzor

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

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Dear colleagues and group members,

 

Here is May’s monthly newsletter, showing a selection of medical devices and regulatory highlights for Russia and the Eurasian Union.

 

  1. Developments in Eurasian Economic Union (EAEU) Medical Device Regulation

“On May 6, 2017, the main regulation acts of the EAEU, ensuring the functioning of the common markets for medicines and medicines, are coming into force” –this statement was made  by the Minister of the Eurasian Economic Commission, Valery Koreshkov, at the very beginning of May. Thus, ten days after the ratification of the protocol on Armenia’s accession by the Kyrgyz Republic, most of the ‘‘second level’’ documents regulating the circulation of medical devices in the single market of the Eurasian Economic Union came into operation. The thirteenth and last ‘‘second level’’ document on the requirements for the quality management system (QMS) has not yet been adopted or entered into force. However, this is not likely to be an obstacle to the launch of a single medical device market.

Later, on 24 May 2017, the Eurasian Commission published the first draft of “third-level” regulations – recommendations on a list of applicable standards to ensure compliance with essential principles of safety and efficacy of medical devices in the EAEU (link in Russian). The document contains a list of 43 standards (mostly Russian GOSTs and Belorussian STBs) which may be voluntarily used by manufacturers and testing laboratories of member states to demonstrate conformity with new Eurasian medical device regulations. The Eurasian Commission recommends that member states implement the list gradually, within six months from the day of its official publication.

In addition to this, Russian healthcare regulator Roszdravnadzor announced an upcoming one day seminar and webcast on the registration of medical devices in accordance with the changes in the legislation of the EAEC. This will take place in Moscow on 8 June 2017. The agenda of the seminar also covers topics relating to clinical trials, vigilance requirements and implementation quality management systems according to EAEU requirements.

  1. Medical Device Nomenclature in Kazakhstan

On 22 May 2017, the Ministry of Health of Kazakhstan approved new nomenclature of medical devices harmonised with the Global Medical Device Nomenclature (GMDN) together with the Methodological Guidelines for the Formation and Maintenance of the Nomenclature of Medical Devices of the Republic of Kazakhstan. Nomenclature of medical devices may be used for registration, traceability, public procurement and post-registration control for medical devices. New medical device nomenclature is available online (link in Russian) and contains a list of medical devices, including their names, relevant codes and descriptions of their types, as well as classification characteristics used for search and classification.

  1. Russian Regulator Updates Checklist for Control Inspections

At the end of April 2017, Russian healthcare regulator Roszdravnadzor published its order #4043 (link in Russian) and updated the “list of regulations containing mandatory requirements, the observance of which is assessed in the course of state control”. The abovementioned list replaced the previous version published by the regulator in November 2016 (Order #12848). Section three of the published list is devoted to state control of medical devices and summarises the full list of applicable regulations which is assessed by Roszdravnadzor during audits and inspections of manufacturers of medical devices and medical facilities in Russia.

 

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The objective of this blog is to clarify Russian and Eurasian regulations. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on Twitter @MedDevRus.

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

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Dear colleagues and group members,

Welcome to my usual update on medical device regulations in Russia and countries of the Eurasian Economic Union (EAEU). Here are my three highlights for April 2017:

  1. Lifting Political Barriers for the Launch of Eurasian Economic Union Medical Device Regulations

    On 5 April 2017, the Kyrgyz Republic endorsed a law “On Ratification of the Protocol on Accession of the Republic of Armenia to the Agreement on Common Principles and Rules for the circulation of medical products within the EAEU”. According to the provisions of the Protocol, Armenia officially joins the above Agreement. Until this date, ratification of this Protocol was one of the main political factors hampering the full launch of the unified medical device market and regulatory model for EAEU countries. The law entered into force ten days after the day of its official publication.

    In this way all the obstacles to beginning the work of a unified pharmaceutical and medical device market have been lifted and all the second-level EAEU medical device regulations (except the quality management system requirements which are not released by the Eurasian Commission yet) are de jure coming into force for all EAEU member states.

    It will be recalled that in recent months official fees for the registration of medical devices according to the new Eurasian procedure were published in Russia, Belarus and Armenia.

 

  1. Statistics on Medical Device Registration in Russia

    At the end of March 2017, Russian medical device regulator Roszdravnadzor published statistics on registration of medical devices for the year 2016. It was reported that 1,465 new medical devices had been approved (which is around 40% higher than the year before) – among them 559 (38%) products manufactured in Russia and 906 (62%) by foreign manufacturers.

    Statistics on MD 2016.jpg
    According to the report, the number of registration refusals decreased by around 9% compared to the year before: the regulator reports 477 refusals with a similar ratio: 163 (34%) for local and 314 (66%) for foreign manufacturers. Roszdravnadzor evaluates the total number of registration refusals for the year as 15.2%.

 

  1. Quality Management System Inspections in Kazakhstan

    On 3 April 2017 the Kazakh medical device regulator (the National Center for Expertise) published a memo (link in Russian) for medical device and pharmaceutical manufacturers clarifying the rules for organising quality management system (QMS) inspection for registration of medical devices and pharmaceutical products. According to the document, for medical device manufacturers QMS inspection is mandatory if a legal manufacturer has never been registered in Kazakhstan before or manufacturing facilities have not been registered in Kazakhstan before, or in cases when conducting an analytical examination is impossible due to the lack or high cost of product samples. The regulator reminds us that the decision about inspection can be taken at any time during the examination. The inspection is carried out within 2-5 working days on one manufacturing site. Valid ISO standard certification of the manufacturer is a necessary condition for the inspection. The Kazak regulator highlights that the manufacturer should: organise the inspection within 30 days after receiving official notification; pay all costs associated with the procedure; and provide translation of necessary information into Russian.

 

Thank you for following this blog! My objective here is to make Russian and Eurasian medical device regulations clearer. You can also follow my updates on Twitter @MedDevRus

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

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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.

 

 

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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.

Russia updated requirements for technical file and instruction for use for medical devices

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On 15 March 2017 the Russian Ministry of Health released the Order #11N ( link in Russian) with full list of requirements for technical file and instruction for use for a medical and in-vitro devices.
It is the first time when these requirements is published as official regulation – until today they were available only as recommendation or voluntary standard, which different interpretation was one of the most common reasons of registration delays.
According to the document the requirements are applicable both for registration and for other stages of a medical device life-cycle.

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

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Dear Colleagues,

Welcome to my monthly update on medical device regulations in Russia and countries of the Eurasian Economic Union (EAEU). Here are my three highlights for February 2017:

 

  1. Prolongation of old forms for registration certificates

    On 14 February 2017, the Russian government released the Resolution 160 (link in Russian).
    The key update on this resolution is prolongation of the deadline for the procedure of administrative replacement of “old” forms of Russian medical device licences issued before 2013.

    Recall that, according to the Resolution 1416 of the Russian government issued at the end of 2012, registration certificates for medical products and medical equipment issued before the date of entry into force of the new registration rules (2013) were to be replaced under a special administrative procedure. Initially, entry into force of the measures was planned for 1 January 2014 and then was postponed until 1 January 2017.

    The Resolution 160 extends these deadlines again for another four years – until 2021, in line with the end of the transition period for Eurasian medical device regulations.

    Russian medical device regulator Roszdravnadzor says more than 10,000 registration certificates were replaced using this procedure from 2013 till 2016. Meanwhile from the other side industry experts assess that up to 10% of licences for medical devices on the Russian market were not updated on time.

    The formal timelines for the administrative replacement procedure according to the Russian regulations is 30 business days; the process for application is described here.

 

  1. Official consulting from Russian medical device regulatory authorities

    Another innovation introduced by the Resolution 160 is the possibility for official consultations on the medical device registration process on behalf of Russian regulatory expert centres involved in the registration process. The resolution addresses Russian medical device registration rules with relevant amendments (see clause 58.1), allowing medical device manufacturers to discuss with authorities specific aspects of the regulatory process and requirements.

    Recall that previously, Russian law did not allow such forms of consultancy, and direct communication between manufacturers and authorities on any specific question was prohibited.

    Considering that lack of transparency still remains one of the key challenges for regulatory professionals in the Russian medical device registration process, such possibility could be especially valuable for medical device manufacturers in the near future.

 

 

  1. Fees for Eurasian medical device registration procedure

    On 22 February 2017, the Russian Duma released a draft federal law aiming to update the Russian tax code. Among other updates and amendments, the document introduces long-awaited information about amount of fees for a harmonized Eurasian medical device registration procedure.

    The total proposed registration fee for a medical device consists of three parts:
    a) Constant registration fee: 7,000 roubles (approx. 120 USD)*
    b) Fee for the expertise: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class
    c) Fee for the “acceptance” procedure: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class for each member state.

    Today, lack of established fees for registration is one of the reasons why a harmonized EAEU medical device regulation model is still not working in practice. One can expect that proposed amendments will come into force from the second half of 2017 after approval of both chambers of the Russian parliament.

                 *RUR/USD rate provided for end February 2017
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The objective of this blog is to make Russian and Eurasian regulations clearer. Please post your comments and questions here or on the  Russian medical device regulations LinkedIn group.

 

 

Three Things You Should Know about Medical Device Regulations in Russia, January 2017

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Dear Colleagues and Group Members,

This is a monthly update with my selection of highlights at the end of January on medical device regulation changes across Russia:

1. Cancellation of “old” forms of Medical Device Registration Certificates.
On 1 January 2017, Russia applied a deadline for the replacement of old forms of registration certificates for medical devices. Despite the fact that this deadline was set and became known four years ago, and the administrative procedure of the replacement was relatively simple (compared to the registration process), several sources have reported a number of cases when medical device companies did not replace their licences in time and for this reason, shipments of products into Russia during the first days of 2017 were stopped. To date, no statistics about the numbers of replacements have been officially published.
The question today is about the regulatory status of medical devices with old forms of “non-replaced” registration certificates which had already been imported into Russia before 2017 – it is unclear if such products can be legally commercialised.
At the same time, it is known that a possible extension of this deadline until 2021 has been suggested, together with other amendments under the current medical device registration rules in Russia. These are now still under the consideration of the Russian government. At the end of the day 30 January, the decision on this consideration has still not been published, so today still such scenario is not excluded.

2.New List of Medical Devices with 0% Value Added Tax
In the first days of January 2017, the Russian government published Resolution #1518 (link in Russian), which amended the list of medical products which were not subject to value added tax (VAT) in Russia. The previous version of the list was published in October 2015.
The new version of the list (link in Russian) contains 45 types of medical products separated into three parts: medical devices, optical lenses and rehabilitation equipment. Medical devices are classified using both “old” all-Russia Product Classification – OKP (for medical devices registered before 2017) and “new” OKPD-2 classification systems.
It should be recalled, that according to articles 149 and 150 of the Russian Tax Code (link in Russian), imports of registered medical devices to Russia should be exempted from VAT in distinction of 10% or 18% for other (medical) products.

3.Request to Report Data for Implantable Medical Devices
At the end of December 2016, the Russian medical device regulator Roszdravnadzor released a letter (link in Russian) aimed at manufacturers of implantable medical devices in Russia and requested them to report data, together with providing customs and finance documentation, for the period from 1 January until 31 December 2016 for the purpose of calculating “weighted-average” prices for each type of implant included in the list of medical devices subject to state healthcare programmes (link in Russian). According to the document, information should be reported using an electronic system, together with hard copies, by 15 March 2017.
The price regulation of medical devices from the list was set in Resolution #1517 at the end of 2015, but the deadline for its implementation has been postponed until the middle of 2017.

Thank you for following this blog! My objective here is to make Russian and Eurasian medical device regulations clearer. You can also follow my news on Twitter @MedDevRus

Отмена кода ОКП или как получить налоговую льготу для медицинских изделий, зарегистрированных в 2017 году?

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okp
Как известно, код ОКП  или общероссийский классификатор продукции, в течение долгого времени использовался (в том числе) для определения ставки НДС при импорте и реализации медицинских изделий в России. На сегодняшний день у зарегистрированных медицинских изделий код ОКП указан на бланке регистрационного удостоверения, а также в нормативной и/или технической документации.

1 января 2017, в соответствии с приказом Росстандарта № 14-ст от 31.01.2014 года, закончился переходный период, и код ОКП был отменен, а вместо него приняты Общероссийский классификатор видов экономической деятельности (ОКВЭД2) и Общероссийский классификатор продукции по видам экономической деятельности (ОКПД2).

В этот же день вступило в силу  Постановление Правительства РФ от 31.12.2016 N 1581 «О внесении изменений в перечень медицинских товаров, реализация которых […], не подлежат обложению […] налогом на добавленную стоимость».  Перечень медицинских изделий, представленный в постановлении классифицирован одновременно как с помощью «старого» кода ОКП, так и  используя «новый» ОКПД2. При этом, согласно Постановлению,  Код ОКП «учитывается в отношении медицинских изделий, зарегистрированных в установленном порядке до 1 января 2017 г.»

Предполагается, что освобождение от НДС для медицинских изделий, зарегистрированных после 1 января 2017 года происходит с использованием «нового» кода ОКПД2.  Однако на середину января 2017 в реестре Росздравнадзора новые медицинские изделия продолжают появляться с указанием  «старого» кода ОКП. Этот же «старый» код ОКП на сегодня все еще необходимо указывать в заявлении на новую регистрацию (согласно п.9 действующих Правил регистрации медицинских изделий).

Каким же образом получить право на освобождение от НДС для медицинских изделий, зарегистрированных в 2017 году?   Что-то похожее большинство производителей медицинских изделий возможно вспомнят из своего совсем недавнего опыта.
Помогут ли тут  переходные ключи для  конвертации кода ОКП в ОКПД2, опубликованные на сайте Министерства Экономического Развития, или следует ждать дальнейшей гармонизации правил обращения медицинских изделий и налогового законодательства?

Three Things You Should Know About Medical Device Regulations in Russia, November 2016.

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Dear Colleagues and Group Members,

It is the end of November, and welcome to my monthly update on the latest news on medical device regulations in Russia:

 

1.      Will the Deadline for Replacement of Registration Certificates be Extended?

One month is left till the deadline to complete procedure of administrative replacement of medical device registration certificates issued before 2013. According to current medical device registration rules, such registration certificates will not be valid after 1 January 2017. Replacement is free for medical device manufacturers and in practice takes 30-60 days. Based on assessment from different sources, only 20-30% of such registration certificates have so far been replaced. The possibility of extending this deadline till the end of 2021 was discussed with the regulator earlier this year by the Russian trade association IMEDA and it is quite good news that this possibility has emerged in a draft of multiple amendments to current registration rules last month. Will this draft be approved by the Russian Government, and will the deadline be extended? We will discover in December.

 

  1. Russia Harmonised National Standards for In Vitro Products

A number of Russian national (GOST) standards for in vitro diagnostic (IVD) (drafts were introduced last year by Russian Agency of Technical Regulation Rosstandart) came into force on 1 November 2016 and replaced older versions. Now Russian IVD standards are completely identical to relevant international ISO standards:

Russian GOST R ISO 18133-1-2015, identical to ISO 18133-1-2009, establishes general principles and specifies essential requirements for information supplied by the IVD manufacturer.

Russian GOST R ISO 18133-2-2015, identical to ISO 18133-2-2009, specifies requirements for information supplied by the manufacturer of IVD reagent calibrators, control materials and accessories for professional use, and defines the requirements for labels for outer and immediate containers and to the instructions for use.

Russian GOST R ISO 18133-3-2015, identical to ISO 18133-3-2009, specifies requirements for information supplied by the manufacturer of IVD instruments for professional use and also applies to apparatus, equipment and accessories intended to be used with it.

Russian GOST R ISO 18133-4-2015, identical to ISO 18133-4-2009, specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing, calibrators and control materials and accessories intended for use with IVD medical devices for self-testing.
Russian GOST R ISO 18133-5-2015, identical to ISO 18133-5-2009, specifies requirements for information supplied by the manufacturer of IVD instruments and accessories for self-testing.

In Russia, the application of standards is voluntary for medical device manufacturers; nevertheless, following these (and other) standards is the best way to demonstrate compliance during pre-clinical testing and expert evaluation within the Russian medical device registration process.

 

  1. List of Regulations for State Control Activity

The Russian medical device domain is regulated at different levels, which can sometimes seem confusing and contradictory. In November, the Russian healthcare regulator Roszdravnadzor published Order # 12848 with a full list of current regulations and legal acts, containing mandatory requirements, compliance with which is assessed during government control activity by the regulator (link in Russian). Chapters ##12 and 13 are devoted to medical devices and service maintenance of medical equipment in Russia. Although this order does not contain any new legislation, it summarises in a single document an exhaustive list of existing Russian Federal Laws, Government Resolutions and other regulations for this domain. From a practical standpoint, the document can be used as a comprehensive checklist for medical device manufacturers represented in Russia to ensure compliance with local regulations.

 
Thank you for following the blog and newsletter. I am always grateful for your comments, and I encourage you to ask specific questions in the LinkedIn group.

 

 

Three Things you should Know about Medical Device Regulations in Russia, October 2016

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Dear Fellow Colleagues and Group Members,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia in October.

  1. Draft of Multiple Amendments to Russian Medical Device Regulations

In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes into current key medical device regulations (i.e., Federal Law 323 and Resolution #1416).  In general, the trend of proposed changes is in line with Eurasian medical device harmonization. The key suggested changes are:

  • extended validity of the “old” forms (issued before 2013) of medical device registration certificates until December 31, 2021;
  • allowance of official consultancy from Russian medical device regulator and expert organizations for applications to register medical devices;
  • simplified procedure of registration expertise of in-vitro diagnostic (IVD) products (single stage examination rather than the current two stage process);
  • implementation of mandatory annual reporting to Russian authorities of information regarding efficiency and safety data for class IIb and III medical devices within three years of registration approval;
  • implementation of mandatory regular reporting to Russian authorities of information on lot/batch numbers of class IIB and III sterile single-use medical devices and class IIB and III IVD products;
  • implementation of “180 day rule” after submission or notification of changes in the registration dossier. Medical devices that are manufactured within 180 days of date of approval of changes in the registration by the Russian regulator can be legally imported and circulated in Russia according “old” registration dossier (before changes are approved) .

Published documents are currently undergoing public and expert evaluation and they are expected to come into force by the end of the year.

 

  1. List of Implantable Medical Devices: New Version

On 22 October 2016, the Russian Government extended the list of medical devices that can be implanted into the human body, subject of state healthcare programmes (link in Russian). Compared to the previous version of the list, 160 new medical devices have been added and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).

Recall that, in accordance with Russian Federal Law №323-FZ, prices for implantable medical devices that are included in state programs and that are included in the list are subject to the state regulation.
The first version of the list, which included 202 medical devices, was published in 2014.
Guidelines (link in Russian) for determining the maximum wholesale mark-up that could be made to the actual selling price of medical devices implanted into the human body were approved and published in 2015.
In August 2016, the deadlines for implementation of price regulation were postponed for one year.

 

  1. New Fees for Amendments to the Registration Dossier

Another draft regulation regarding state fees for amendments to the registration dossier was published (link in Russian) by the Russian Ministry of Health in October 2016. Currently, amendments to the registration dossier (according to Clause 55 of Russian medical device registration rules) are free for applicants and mandatory when technical or quality characteristics of the approved medical device are changed.  The new document implements the following fees:

– amendments to the registration dossier for a medical device – 3,500 rubles (55 USD)

– procedure of expertise of amendments to the registration dossier 30,000 rubles (460 USD) – 55,000 rubles (850 USD), depending on the safety class of the device.

 

The objective of this blog is to make Russian and Eurasian regulations more clear. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on Twitter @MedDevRus.

Какие решения принимают российские суды в делах об обращении незарегистрированных, недоброкачественных и фальсифицированных медицинских изделий и лекарственных средств?

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English version of this post is comming soon…

Почти полтора года прошло с момента вступления в силу Федерального Закона № 532 и введения уголовной и административной ответственности за нарушения в области обращения медицинских изделий.  В течение последнего времени Росздравнадзор неоднократно сообщал об усилении контроля,  увеличении объема проведённых экспертиз качества, эффективности и безопасности медицинской продукции,  выявлении миллионов единиц медицинских изделий, не соответствующих установленным требованиям и пресечении деятельности недобросовестных участников рынка. Но доходят ли эти дела до суда, и  какие решения принимаются на этом уровне?  Попробуем исследовать этот вопрос, изучая открытые базы судебных решений, практика по которым начинает появляться.
Мой небольшой обзор на эту тему:

1.Решение суда от 11 мая 2016 года по делу 1-164/2016 г. Самара
Суть дела: незаконный сбыт незарегистрированных медицинских изделий в крупном размере (ст. 238.1 УК РФ).
Категория дела: Уголовное
Решение суда/ приговор: Лишение свободы на три года (условно).

2.Решение суда от 27 августа 2015 года по делу 1-600/2015 г. Ростов-на-Дону
Суть дела: незаконный сбыт незарегистрированных лекарственных средств (ст. 238.1 УК РФ).
Категория дела: Уголовное
Решение суда/ приговор: Лишение свободы на два года (условно).

 

3.Решение суда от 25 апреля 2016 года по делу № А56-14465/2016, г. Санкт-Петербург
Суть дела:  продажа недоброкачественных лекарственных препаратов для медицинского применения, качество которых не отвечает установленным требованиям нормативной документации (ст. 6.33 КоАП РФ).
Категория дела: Административное
Решение суда: штраф 500 000 рублей.

 
4.Решение суда от 28 апреля 2016 г. по делу № А19-3703/2016, Иркутская область
Суть дела: реализация индивидуальным предпринимателем  недоброкачественных медицинских изделий (ст. 6.33 КоАП РФ).
Категория дела: Административное
Решение суда:  штраф 50 000 рублей

 

5. Решение суда от 08 апреля 2016г. по делу 5-104/2016 г. Тольятти 
Суть дела: реализация индивидуальным предпринимателем фальсифицированных медицинских изделий (ст. 6.33 КоАП РФ).
Категория дела: Административное
Решение суда: штраф 70 000 рублей.