Tag Archives: Registration

Three Things You Should Know about Medical Device Regulations in Russia, August 2015

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Dear  colleagues,

I hope you all enjoyed your summer holidays! Allow me to deliver my usual monthly update of the most important regulatory news in the medical device industry for Russia, the Eurasian Economic Union (EEU), and the CIS region:

 

  1. Possible expansion of restrictions on state procurement for foreign manufacturers of medical devices.

In August 2015, the Russian Ministry of Industry and Trade (Minpromtorg) proposed the introduction of a new set of restrictions on the state and municipal procurement of imported medical devices. A new legal initiative proposes to considerably expand the list ‘of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’ adopted in February 2015 by way of Decree #102 (link in Russian) which has already imposed a ban on applications to tender for state and municipal procurements for foreign manufacturers of 45 types of medical devices, provided there are two or more entries from manufacturers in Russia, Belarus, Armenia, and Kazakhstan.
The draft of the new initiative, which was published (link in Russian) on the 3rd of August 2015, generated active discussions and an unsought avalanche of attention from the Russian medical device industry as well as non-governmental organisations. “Public discussions” concerning the draft will continue until the 1st of October 2015.
State procurement restrictions may affect antiseptics, disinfectants, medical dressings, some orthopaedic and rehabilitation equipment, condoms, artificial heart valves, defibrillators, dental and endodontic instruments, certain types of ultrasound and X-ray equipment, and some other medical devices. In addition to the 45 medical devices affected in February, there are now more than 90 types of medical devices under discussion.
One should recall that the key strategic objective for Minpromtorg is ‘40% of medical devices for state procurements to be manufactured within Russia till 2020’.

  1. Harmonised Eurasian regulations for medical devices – four months to go.

The Eurasian Commission published a new series of “second level” guidelines concerning anagreement on common principles and rules of circulation of medical devices in the Eurasian Economic Union (EEU).
In August 2015, drafts of the following documents became available:

  • Common Eurasian rules on safety and vigilance monitoring of medical devices (link in Russian).
  • Eurasian rules for medical devices with measuring function (link in Russian).
  • Common Eurasian nomenclature for medical devices (link in Russian).
  • Guidance for conducting clinical trials for medical devices in EEU (link in Russian).
  • Rules for the common Eurasian informational database for medical devices (link in Russian).
  • Common Eurasian requirements on quality management system for medical device manufacturers (link in Russian).

The Eurasian Commission is expected to approve these drafts by the end of September 2015. All approved documents on the Eurasian medical device integration initiative can be found on the official website of the Eurasian Commission.
It is expected that the new medical device regulation system will come into effect in Russia, Kazakhstan, and Belarus on the 1st of January 2016. In these countries, the new system will overhaul regulation approaches for all stages of the medical device lifecycle.
EEU regulations MD

  1. Update on regulations of narcotic substances for medical products

On the 8th of August 2015, the Russian Ministry of Health enforced amendments for the decree #157n (link in Russian) ‘On approval of the maximum allowable amount of narcotic drugs, psychotropic substances and their precursors, contained in medical products’. This decree regulates the maximum amount of such substances permitted per 1 mL of pharmaceutical product or medical device. This may be pertinent to some IVD and dental adhesive materials. The updated and finalised list of substances can be found by following the link in Russian.

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

Three Things You Should Know about Medical Device Regulations in Russia and CIS, July 2015

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Dear Colleagues,

Welcome to my monthly update of the latest medical device regulatory initiatives and news for Russia, CIS and the Eurasian Economic Union (EEU):

  1. Russia simplified approval process for Class I medical devices
    On 17 July 2015, the Russian Ministry of Health enforced the Decree #303 dated 3 June 2015 (link in Russian), which simplified the approval process for Class I medical devices. Since this, Class I medical devices submitted for registration will pass through only the second phase of quality and safety expertise (10 business days process) – for these products the first phase of expertise, as far as requirement to undergo clinical trials, will be excluded from theregistration procedure. For the fastest approval of low class devices, Roszdravnadzor (Russian medical device regulator) recommends submitting in the registration dossier documents confirming clinical efficiency and safety (clinical reports and literature review). For now it has not been clarified whether the regulator will accept clinical reports covering clinical data from global markets provided by the manufacturer, or whether this report should be provided by Russian clinical centres as far as clinical data for similar (analogue) devices will be acceptable for registration.

  2. Medical device registration rules for EEU
    The new rules of registration of medical devices for the future harmonized system in the EEU, is the most important and anticipated legal act among second level regulations after the approval of the Agreement on Common Principles and Rules for Circulation of Medical Devices (link in Russian) between Russia, Belarus and Kazakhstan in December 2014. At the beginning of July 2015, the draft of new registration rules was published on the website of the Eurasian Economic Commission. The draft of the new rules describes the new approval and amendment processes, provides timelines for its main steps, and sets a number of new regulatory requirements. You can see my detailed review of the published document by following the link.

  3. New safety monitoring requirements for Kazakhstan
    In July 2015, Kazakhstan published new rules for the safety monitoring of medicines and medical devices (link in Russian). Up to now, Kazak legislation did not contain detailed post-market and vigilance requirements for medical devices.
    According to the new document, henceforward the license holder shall report to the competent authority (the committee for monitoring the medical and pharmaceutical activity of the Ministry of Health of Kazakhstan) on adverse reactions and serious side effects, and the lack of effectiveness of medical devices. Clause 56 of the published document establishes target dates for reporting as:
    – 48 hours for fatal or life-threatening adverse reactions
    – 15 days for other serious adverse reactions, severe unexpected reactions, and side effects or adverse reactions during clinical trials.
    The foreign license holder must have a responsible representative person on the territory of Kazakhstan and ensure process to receive complaints within 48 hours (see clause 66).
    The document also sets deadlines for periodic safety reports (clause 80) and contains the template for the special reporting form for medical device safety reporting (see attachment two).

Обзор проекта единых правил регистрации медицинских изделий Евразийского экономического союза.

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The English version of this post is coming soon

После подписания соглашения о единых принципах и правилах обращения медицинских изделий  Евразийского экономического союза в декабре 2014 года новые правила регистрации медицинских изделий для будущей гармонизированной системы можно назвать самым важным и ожидаемым нормативным актом из документов второго уровня.  В начале июля 2015 года  проект был опубликован на сайте Евразийской экономической комиссии.

Представляю Вашему вниманию мой небольшой обзор основных нововведений проекта и наиболее значимые отличия новых правил от действующих регуляторных систем  России, Беларуси и Казахстана:

  1. Признание по умолчанию?
    Судя по тексту проекта, новые правила не подразумевают единой регистрации на всей территории Евразийского экономического союза «по умолчанию». В начале документа вводятся понятия «референтное государство» – страна, в которой предполагается полный цикл регистрации с экспертизой  и «государства признания» – страна признающая результаты экспертизы и «подтверждающая» регистрацию путем упрощенной пятнадцатидневной процедуры.
    По тексту проекта как «референтное государство», так и «государство признания» выбираются заявителем в начале процедуры, а после завершения регистрации закрепляются на титуле регистрационного удостоверения (см. приложение №13).
    Указана возможность НЕпризнания другими государствами экспертного заключения референтного государства (см.п. 32), что, согласно проекту, является основанием для запрета обращения медицинского изделия на территории отдельного государства Евразийского экономического союза.
    На мой взгляд, из текста документа не ясен ответ на достаточно важный вопрос о том,  необходим ли уполномоченный представитель производителя в каждой стране Союза или же достаточно одного?
  1. Переходный период:
    Наверное, самая хорошая новость – в начале 2016 года перемены, скорее всего, не будут очень резкими! Пункт 3 единых правил вводит  переходный период.  Согласно проекту, в течение этого времени регистрация медицинских изделий может быть осуществлена по выбору заявителя. Досье может быть подано либо в соответствии с уже работающими национальным законодательством союзных государств,  либо в соответствии с новой гармонизированной процедурой.  При этом следует помнить, что  согласно п.15 соглашения о единых принципах и правилах обращения медицинских изделий,  документы, подтверждающие факт государственной регистрации медицинских изделий и выданные только в одном союзном государстве будут действительны максимум до 31 декабря 2021 г.
  2. Новые определения:
    Единые правила регистрации вводят новые определения для комплектующих, модификаций, принадлежностей и расходного материала для медицинских изделий (а также некоторые другие) – до настоящего времени эти понятия в России вызывали много вопросов, поскольку были закреплены только на уровне национальных стандартов.
  3. Процедура внесения изменений:
    На сегодняшний день в России (в отличие от Беларуси и Казахстана) закреплены две отдельные процедуры: внесение изменений в регистрационное удостоверение (п.37 правил регистрации 1416) и внесение изменений в регистрационные документы (п.55 правил регистрации 1416). Судя по моему опыту, данное разделение процедур не всегда очевидно и порой вызывает много дополнительных вопросов у производителя. Новые правила регистрации вводят единую процедуру внесения изменений в регистрационное досье.  Изменения, согласно проекту, могут проводиться с выдачей или без выдачи нового регистрационного удостоверения. В документе достаточно детально указаны причины для этих изменений (см. раздел IV).
  4. Классификация и номенклатура:
    Согласно п.15 проекта «При условии одновременной подачи на регистрацию нескольких модификаций медицинского изделия, относящихся к одному виду медицинского изделия в соответствии с принятой в Союзе номенклатурой […] заявитель представляет одно заявление и одно регистрационное досье». Следует вспомнить, что п. 2 ранее подписанного Соглашения о единых принципах обращения медицинских изделий предполагает “гармонизацию номенклатуры медицинских изделий, используемой в государствах–членах, с глобальной номенклатурой медицинских изделий GMDN” .  На практике данное изменение может привести к значительному увеличению количества заявлений и регистрационных досье (по сравнению с более ранними регистрациями, особенно в  Беларуси и Казахстане). Как известно, новые системы номенклатурной классификации медицинских изделий были недавно приняты и уже работают в России  и Беларуси.
  5. Экспертиза:
    В отличие от действующих регуляторных систем, новыми правилами предложена одноэтапная экспертиза продолжительностью не более 60 рабочих дней. (Для сравнения: сегодня в России и Беларуси экспертиза медицинских изделий проходит в два этапа с официальными сроками от 15до 30 рабочих дней, в Казахстане – 3 этапа, продолжительностью до 180 рабочих дней).
    Не секрет, что сегодня в России на этапе экспертизы у заявителей появляется наибольшее количество сложностей. Пункт 23 новых правил достаточно подробно описывает основные этапы экспертизы медицинских изделий в рамках новой процедуры регистрации. В случае недостаточности сведений новые правила разрешают однократный запрос дополнительных материалов экспертной организацией со сроком 60 рабочих дней для предоставления этих материалов заявителем (сегодня этот срок в России составляет 50 рабочих дней, в Казахстане – 30 рабочих дней).
  6. Инспекция производства:
    На сегодняшний день инспекция производства – наиболее сложный этап регистрации медицинских изделий в Беларуси и Казахстане, который применяется в довольно ограниченном количестве случаев. Проект единых правил  (см. п. 22) значительно расширяет показания к инспекции в рамках контроля системы менеджмента качества производителя,  предполагая  инспекцию производства для регистрации всех медицинских изделий высокого класса риска и стерильных изделий класса 2а. Общее время на организацию и проведение такой инспекции, согласно проекту, не должно превышать 90 рабочих дней.
  7. Инструкции и маркировка:
    Новым для российской системы обращения медицинских изделий будет требование одобрения и утверждения регулятором макетов упаковок и инструкций с их размещением на официальном сайте (см. п.28 и п.35). По аналогии с действующими правилами регистрации в Казахстане, в  проекте новых правил выделен отдельный этап подтверждения для лейблинга медицинских изделий (см. п.24):  «после оформления экспертного заключения уполномоченный орган (экспертная организация) референтного государства (государства признания) в срок, не превышающий 30 рабочих дней, подтверждает правильность перевода руководства пользователя (инструкции по медицинскому применению), маркировки на государственные языки в соответствии с требованиями законодательства государств-членов».
  1. Предварительные консультации:
    Проведение официальных консультаций – интересное и давно обсуждаемое нововведение. Пункт 6 правил устанавливает возможность предварительных консультаций для заявителя от экспертной организации «по всем вопросам экспертизы и регистрации».
    На своих конференциях и семинарах представители Росздравнадзора давно говорили об этой возможности и отсутствии юридических механизмов для ее осуществления. Напомню так же, что на сегодняшний день консультации и контакты заявителя с экспертной организацией в рамках процедуры регистрации в России официально запрещены.
  2. Сроки регистрации:
    Проект новых правил вводит следующие сроки для основных этапов процедуры регистрации медицинских изделий:
  • 5 рабочих дней на проверку полноты и достоверности регистрационного досье;
  • 3 дня для начала процедуры регистрации;
  • 60 рабочих дней на проведение экспертизы для регистрации;
  • 30 рабочих дней на экспертизу для внесения изменений;
  • 90 рабочих дней на организацию инспекции производства;
  • 30 рабочих дней на подтверждение правильности перевода инструкций и маркировки;
  • 15 рабочих дней на процедуру признания в выбранных странах Союза.Новые правила устанавливают так же следующие сроки для устранения замечаний:
  • 30 рабочих дней на этапе оценки полноты и достоверности регистрационного досье;
  • 60 рабочих дней на устранение замечаний экспертной организации.

Я хотел бы напомнить, что данный документ на данный момент является проектом и проходит стадию общественных обсуждений на официальном правовом портале Евразийской экономической комиссии.

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

Буду рад дополнениям и комментариям.

Nine Questions about Registration of Medical Devices in Russia

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На русском

“A complex landscape, which is continuing to be adjusted” …this quote, by the head of the medical device expertise body, is a description of what is going on today in the regulation of medical devices in Russia and was the main idea behind ​​the seminar on the registration of medical devices in Russia, held by the medical device regulator on the 6th and 7th of April in Saint-Petersburg. In addition to the official reports of experts, a lot of time at this event was assigned to live discussion, with representatives of Russian and international medical device companies. I would like to highlight below the most interesting of these questions which were answered by the experts:

  1. Question: Is it allowed to group in one registration submission several medical devices of different types according to the Russian nomenclature classification?

    Expert answered: No. It is possible to group medical devices only within one type of nomenclature classifier.  This question is still open for renewals of registrations already granted, and Roszdravnadzor (the Russian medical device regulator) is considering the possibility of listing multiple types of medical devices in the registration certificates issued previously.

  2.  Question: What should I do if the type (code) of my medical device is not listed in the nomenclature classifier?

    Expert answered: Roszdravnadzor is working to keep the national medical device nomenclature classifier updated and harmonized with global medical device nomenclature (GMDN).  If the type (code) of a medical device is not listed in the current version of the classifier, it is recommended to submit the code GMDN for the medical device in the technical file. In this case, the regulator will assign a similar Russian code.

  3. Question: Can I get a formal consultation on the registration process with Roszdravnadzor or an expert organization?

    Expert answered: Currently, Roszdravnadzor does not consult applicants. Any question about the registration of medical devices is only possible in the form of a written request.  It should be noted however, that Roszdravnadzor is currently considering legal mechanisms for the possibility of such consultations in the future.
    Expert organizations also do not provide consultation options for applicants, and they conduct their activities only upon request of Roszdravnadzor. According to the Decree of Ministry of Health number 1353N, direct communication between experts and applicants is prohibited. If the applicant has any query for the expert organization, it should apply to Roszdravnadzor.

  1. Question: Who and how determines if a borderline product (e.g. medical device, pharmaceuticals, biological product) can be registered as a medical device?

    Expert answered: Before the registration of borderline products, this question should be addressed (with a technical file and IFU) to the special interdepartmental commission convened regularly by Roszdravnadzor.
  2. Question: Is Russian registration mandatory for a medical device manufactured in Russia for export sales only?

    Expert answered: Yes. Manufacturing is part of the life-cycle of a medical device; therefore, registration is mandatory in order to start production of any medical device in Russia, even if it is for export purposes only.

 

  1. Who and at what stage of the registration process defines whether a medical device will undergo full clinical trials, or only evaluation of clinical data for the registration?

    Expert answered: After the first stage of the expertise and obtaining the authorization of Roszdravnadzor, the clinical investigation plan, including study design, should be developed by the applicant together with an accredited clinical center. It is an obligation for the applicant to provide an appropriate evidence base in order for the clinical center to make a decision about how clinical data could be obtained.

 

  1. Are there any requirements for the design plan of the clinical trial?

    Expert answered: A program of clinical trials can be drafted in any form and should contain the information required by ISO 14155-2008

  2. Question: How can I perform clinical trials of an analyzer and in-vitro reagents, if these items should be submitted for registration separately?

    Expert answered: Such items should undergo clinical trials and technical testing together. The same rule applies to analytical systems, components of which are registered as individual medical devices (glucometers, test strips, test solutions).

  1. Is clinical usage of a medical device authorized when the registration certificate has expired?Expert answered:

    Yes. According to the explanation of the Ministry of Health, if a medical device was imported into Russia, and purchased by a clinical center during the period of validity of the registration certificate, then such a medical device can be used for clinical purposes until the end of lifetime indicated in the IFU.

Disclaimer: the objective of this post is solely to provide information about the seminar that I found interesting from my professional point of view. This post is NIETHER an official report NOR recommendation and does NOT state official position of any organization or regulatory body.

52% of Resondents Found that Russian Approval Process Became More Difficult.

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More than 52% of respondents of the Medical Device Industry Survey, published by Emergo Group,  consider getting regulatory approval for a medical device in Russia is now MORE DIFFICULT than it was one year ago. According to the Review, China, Russia and Brazil continue to frustrate RA professionals due to long review times, new regulations released and lack of transparancy.

http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey?utm_source=RADAR&utm_medium=newsletter&utm_term=4pm&utm_content=Worldwide&utm_campaign=22Jan2015

Seven Questions on Medical Device Testing for Approval in Russia.

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Russian medical device registration system relies on product testing, and this testing must be completed regardless of whether the device already has FDA, European or other countries` approvals. According to the registration procedure this testing should be done before submission of the registration dossier. The main regulation for medical device testing is The Order #2N by Russian Ministry of Health dated 09.02.2014 (link in Russian). Here I would like to provide the most common questions on this topic:

  1. What tests should be performed for the registration of medical devices in Russia?
     -Before submission all medical devices must pass through technical testing.
    -For active medical devices, testing for electro-magnetic compatibility (EMC) is a mandatory part of technical assessment.
    -If a medical device or it`s accessory has a contact with patient`s body, toxicological testing must be completed.
    – If a medical device is sterile or has a contact with a blood, sterility, pirogenicity and hemocompatibility testing are a mandatory part of toxicological testing.
    – If a medical device is considered to have measuring function, special testing on measurement assessment should be done.
    ***
  2. Who defines which laboratory will perform tests?
    The applicant (manufacturer or its representative) can chose a testing laboratory. Technical, toxicological and EMS testing are usually performed by different centers. The testing laboratory must be accredited by Russian medical device regulator (Roszdravnadzor).
    ***
  3. What should I provide to a laboratory in order to start technical testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Copies of technical reports performed by the manufacturer,
    -Special testing equipment (if applicable in technical file),
    -Information about clinical application of a medical device,
    -Risk management file for a medical device,
    -Technical file and instruction for use,
    –Photo of a medical device,
    -Technical drawings or charts.
    ***
  4. Can technical testing be completed without samples?
    Yes, the technical testing can be completed without providing samples in limited cases: if a medical device is subject to special authorizations or special conditions for installation or/and requires construction of specialized capital facilities. In this case testing can be performed under form of data/document analysis or manufacturing site inspection.
    ***
  5. What exactly is tested in a technical laboratory?
    Technical lab will:
    -Identify a medical device and confirm it`s classification, customs (OKP) code and safety class,
    -confirm that a medical device is compliant with requirements and characteristics described in the technical documentation,
    -Confirm that medical device is compliant with applicable Russian standards e.g. GOST 50444-92 General specifications for Medical instruments, apparatus and equipment, GOST 50267.0.2-2005 General requirements for safety. Electromagnetic compatibility. Requirements and test methods for medical devices , GOST R ISO 14708-1-2012 for implantable medical devices etc.
    -confirm that technical documentation contains full set of characteristics and is compliant with Russian regulations and national standards.
    ***
  6. What should I provide to a laboratory to start toxicological testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Technical file and instruction for use,
    -Copies of biocompatibility reports performed by the manufacturer,
    -Documents with a detailed description and chemical composition of all materials of a medical device and its accessories,
    -For combination products containing medical drugs, pharmacopeia reference should be provided.
    ***
  7. What exactly is tested in a toxicological laboratory?
    Toxicological laboratory will confirm that a medical device is compliant with national standards e.g. GOST ISO 10993 biocompatibility standards or specific GOST 52770-2007 standard for toxicology testing and will confirm its biological safety.

Do you have other questions on this topic? Post them here!

Three Things You Should Know about Medical Device Regulations in Russia, October 2014

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October 2014 was remarkable with a series of “big events” on the Russian regulatory landscape which opened up possibilities to get first-hand information from Russian regulatory bodies: a public seminar by Roszdravnadzor on clinical trials, a big conference “Farmmedobrashenie” and a public discussion on “Federal Act on Medical Devices”.

The first interesting statistics on registration of medical devices for this year appeared: the Head of Medical Device registration department announced that there were 1176 positive and 428 negative expertises for registration of medical devices in 2014. It was also stated that after new amendments to registration rules came into force in July, the number of positive outcomes has been rising rapidly, more than tripling, and the quantity of negative outcomes for last two months consisted of 7%.

But…here are the three most important news items I would like to highlight:

  1. Eurasian Economic Union – ratification is completed.
    The Treaty on the Eurasian Economic Union signed by Russia, Kazakhstan and Belarus on 29th May 2014 was ratified by all countries of the Union. Russia officially ratified the document on the 3rd of October, Belarus on the 9th of October and Kazakhstan on the 14th of October. It should be reiterated that the document will come into force on the 1st January 2015 and defines, amongst others, common rules for circulation and registration of medical devices and one registration certificate valid throughout the whole EAU territory from January 2016.  Current “local” registration certificates will be valid within a transition period until 31st December 2021 and will require re-registration according to the new EAU procedure before this deadline.
  1. First edition of the list of implantable medical devices is expected on the 18th of November.
    Strict deadlines (the 6th of October) to submit the dossier for official lists “subject to state reimbursement programmes for implantable medical devices” caused a bustle in the medical device industry at the beginning of the month. Over several days 829 dossiers have been submitted from 72 applicants including manufacturers, distributors, clinical centres and professional associations. The Russian MoH promised to publish the first version of the list after the first Commission session on the 18th of November and also confirmed deadlines for submission for next year`s edition of the list as March 2015.
  1. Federal Law on Medical Devices – the text is available for discussion.
    The text of the draft of the Federal Law on Circulation on Medical Devices became available and became the subject of discussion and critiques on different levels. The current version of the draft describes the powers of federal bodies and stipulates the regulation of medical devices’ circulation throughout their entire life cycle including importation, registration, advertisement, distribution, safety monitoring etc. The draft is available in Russian here.