Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in November 2018

Dear Colleagues,

Welcome to my monthly review of updates on the medical device regulations landscape in Russia and the Eurasian Union for November 2018:

 

  1. First Registration Files for Eurasian Medical Device Registration Procedures and other Eurasian Medical Device Regulations Updates

“The first applications for registration under the Eurasian Economic Union (EAU) medical device system have been filed for review by competent authorities of Kazakhstan and Russia.” It was announced by the Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) in Moscow at a conference organized on 15 November 2018 in Moscow by the medical device manufacturers association IMEDA together with the European Association MedTech Europe and EEC. During the same event it was announced that the unified information system for registration of medical devices  will be launched “in full mode” by the end of this year. Unreadiness of this system was, until now, considered as one of the main barriers to starting registration procedures for the harmonized market.

In addition, on 16 November 2018, the EEC published approved versions of several third-level documents:

  • Regulation # 25 – On criteria for classifying products as medical devices in the EAU (link in Russian);
  • Regulation #176 – On the single register of organizations conducting testing/trials of medical devices for registration in the EAU (link in Russian);
  • Regulation #177 – On the single database on safety monitoring of medical devices in the EAU ( link in Russian);

Earlier in November, the EEC published English translations of all second-level Eurasian medical device documents. The link is available on the official EEC website.

 

  1. Clarification on Valued Added Tax (VAT) for Medical Devices

On 2 November 2018, The Russian Ministry of Finance published a clarification letter (link in Russian) on exemption from VAT for the importation and sale of medical devices in the Russian Federation.

According to the letter, medical devices imported and sold in Russia are exempt from VAT if two conditions are met: the first is the presence of a registration certificate for the medical device, and the second is the inclusion of the product in the list of devices, approved by government resolution No. 1042 of 30 September 2015.

 

  1. Update of some Medical Device National Standards in Russia

 It is important and often critical to use the most updated version of the national standards for the preparation of the technical documentation, testing, and assessment of medical devices in Russia. Several GOST standards relevant for registration of medical devices in Russia will be updated within the next two months.

Thus, on 1 January 2019 the new versions of the following national standards will come into force:

  • Sterilization of health care products. Moist heat (Part 3). Guidance on the designation of a medical device to a product family and processing category for steam sterilization (link in Russian);
  • Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 (link in Russian);
  • Medical devices utilizing animal tissues and their derivatives (link in Russian);

On 1 February 2019 the following national standards will also come into force:

  • Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multi-functional patient monitoring equipment (link in Russian)

 

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Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.

 

 

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, October 2018

Dear Colleagues,

This is my usual monthly review for October with a selection of the latest medical device regulation changes across Russia, the Eurasian Union, and other CIS countries.

 

  1. Updates on Eurasian Medical Device Harmonisation

 

Several interesting small updates happened in the development of Eurasian medical device harmonisation in October 2018:

 

  • At the beginning of October 2018, the competent authorities of Kazakhstan officially suggested to the Eurasian Economic Commission (EEC) to prolong until 2025 the transition deadline from local to the Eurasian medical device registration system (you may recall that current Eurasian regulations set this deadline as 2021). Experts from the EEC announced that the possibility of shifting the transition period is currently being discussed, however, a final decision on the deadline is not yet clear;
  • A very convenient update is the creation of a separate section on Eurasian medical device regulations on the website of the Eurasian Commission (link to the section). The section summarizes a list of Eurasian medical device regulations, a description of approval procedures according to medical device classification, registration documents checklists, a list of competent authorities and accredited laboratories, a database of registered medical devices, and safety monitoring for the Eurasian Union. Materials are currently provided in Russian;
  • Another October update is a draft of the methodical guidelines for medical device registration expertise for Eurasian registration, published (link in Russian) by the EEC. The document is intended to establish uniform approaches to the examination of medical devices and the unification of expert requirements across competent authorities of Eurasian member states for the assessment of the content of the registration dossier.

 

  1. Tightening of Responsibility for Online Medical Product Violations in Russia

In October 2018, the Russian Duma introduced a draft law (link in Russian) that stipulates a tightening of administrative and criminal responsibility for the circulation of counterfeit, poor-quality, and unregistered medicines and medical devices through the internet.

The responsibility for the distribution of falsified, poor-quality, and unregistered medical products was introduced in Russia in 2015, however, the bill emphasised the responsibility for the violations of the distribution of medical products via the internet.

The document meets the requirements of the international MEDICRIME Convention against counterfeit medical products and similar crimes involving threats to public health, which was signed by Russia in 2011 and ratified in 2018.

  1. Possible Regulatory Exclusions for Certain Medical Devices in Ukraine

On 1st October 2018, the Ministry of Health of Ukraine published a draft regulation (link in Ukrainian) that suggested authorising the importation of medical devices and in vitro diagnostics that are necessary in cases of emergency, the implementation of international technical assistance programmes, and some other conditions without the need for established approval/conformity assessment procedures. The document suggests a simplified ten-day application procedure for getting authorisation for the importation of specific batches of medical devices which meet the above-mentioned criteria.

 

 

 

Three Things You Should Know about Medical Device Regulations in Russia, January 2018

Dear Fellow Colleagues,

 

Welcome to my monthly newsletter with my selection of highlights in medical device regulations in Russia. Here are the most important updates for January.

 

 

  1. Road map to Development of Competition in Public Health Sector

 

On the 12th January 2018, the Russian Government published resolution #№9-р (link in Russian) with a roadmap to “developing competition in healthcare” for 2018–2019.
The published document contains a list of suggested strategic measures to develop competition in the public market for medicines, medical devices, healthcare services, and biologically active supplements in Russia, in the coming years.

A significant part of this document is devoted to changes in the regulation of medical devices expected in the next two years. Thus, among others, the following measures were suggested:

 

  • Development of the concept of medical devices of the “open” and “closed” types in terms of the possibility of using consumables or reagents from other manufacturers and the duty of the state and municipal customers to purchase medical products of an “open” type.
  • Development of the concept of the interchangeability of medical devices.
  • Introduction of a ban for manufacturers to set restrictions on the possibility of using consumables/reagents from other manufacturers.
  • Inclusion in the technical documentation for medical device information on the period of operation costs of technical maintenance and repair, costs of training medical personnel for the rules of application, and operation of the medical device.

 

The document also mentions a number of measures to improve and develop the regulation on the procedure of state and municipal procurement of medical products. The full text of the road map is available on the website of the Government of the Russian Federation.

 

 

  1. Checklists and Year Plan for Inspections

 

On the 26th January 2018, the Russian medical device regulator, Roszdravnadzor, published the approved forms of checklists (lists of control questions) that are used by the regulator during routine control inspections/audits of medical device manufacturers and other organisations involved in the turnover of medical devices in Russia.

In total, seven checklists have been published for the monitoring at each stage of the medical device lifecycle (control of pre-registration testing, clinical trials, usage and application in clinics, control of medical device manufacturers and its authorised representatives, technical maintenance, transportation, and storage). The checklists clarify whether organisations are complying with the mandatory requirements set by Russian medical device regulations and standards; they could also be a useful tool for audit preparation.

The list of organisations planned for inspection by Roszdravnadzor in 2018 has been published by the regulator in the beginning of January.
 

  1. Amendments to Regulation of Medical Products Containing Alcohol

 

On the 1st January 2018, article #14 of the Russian federal law #171 (link in Russian), the “regulation of turnover of ethyl alcohol, alcoholic, and alcohol-containing products” came into force. According to the updated regulations, Russian companies carrying out the production, manufacturing, and/or turnover of medical products containing alcohol exceeding 200 decilitres per year are obliged to register and declare this volume of alcohol-containing medical devices in accordance with the established procedure. The regulation defines an alcohol-containing medical device as “medical products in a liquid form of release containing a pharmaceutical substance of ethyl alcohol.”
Another amendment to this federal law was enforced in late December 2017 and establishes that until the 1st July 2018, non-declaring of this information by a company is not considered a violation.

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

 

Dear Colleagues and Group Members,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia for August 2017.

 

  1. Restrictions for Plastic Consumables

In August 2017, the Russian government introduced two important regulations affecting public procurements of a broad range of medical devices made from polyvinyl chloride (PVC) plastics.
According to Resolution # 967 (link in Russian), which came into force on 25 August 2017, suppliers to the Russian market of medical devices manufactured with PVC will from now on be determined from the list of organizations implementing projects to localize the production of medical products in Russia in 2017–2024. The Resolution also sets rules for selecting such suppliers. In particular, organizations must have the right to technical documentation for the respective devices for a period of not less than ten years, and use technologies and raw materials developed within the framework of the Russian “Development of the pharmaceutical and medical industry” programme for 2013–2020.
At the same time, another adopted Resolution # 968 (link in Russian) includes six groups of disposables made of PVC plastics in the list of medical products for which state procurement from foreign manufacturers will be limited  (according to the Resolution #102 dated from February 2015).

 

 

  1. Draft Resolution on Changes to Russian Medical Device Registration Rules

The draft Resolution on Amendments to State Registration of Medical Devices is another important document which was published (link to the draft in Russian) at the beginning of August 2017. The main change proposed in the draft is a simplification of registration of in-vitro diagnostics (IVD): by analogy with the simplification of procedures for I class devices introduced in 2015, the document proposes one-step expert assessment (so called expertise) for registration instead of the current two-step pathway. Another possible innovation proposed in the draft is a significant change of procedure in the amendment of registration certificates and registration dossiers (product re-registration): it proposes a list of changes which do not require expert assessment for re-registration, and establishes a timeline for such re-registration as 15 working days.
As of the end of August 2017, a draft of the document is undergoing regulatory impact assessment by Russian authorities.
 

  1. Adopted Changes in Alcohol Regulations will affect some Medical Devices

On 29 July 2017, Russian authorities adopted Federal Law № 278-FZ (link in Russian), which changes measures to control the turnover/distribution of pharmaceutical substances of ethyl alcohol, including in the production of alcohol-containing medical devices. The regulation defines “alcohol-containing medical device” as a medical device in a liquid form, containing a pharmaceutical substance of ethyl alcohol (ethanol). The published law requires, in particular, additional registration and declaration procedures for legal entities that carry out the manufacturing and turnover/distribution of alcohol-containing medical devices in Russia. According to the regulation, lists of exceptions are established, i.e. “alcohol-containing medical devices” not covered by this regulation. These changes will become operative from 1 January 2018.

 

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Five Things to Know about Medical Device Regulations in Russia in 2016

Dear fellow colleagues and group members,

 

As the year is coming to a close, in my final post of 2016 I would like to summarise the most remarkable and important updates that have taken place in medical device regulations in Russia and the Eurasian Union this year. Thus, here is the 2016 Russian regulatory environment at a glance:

  1. First Year of the Eurasian Union Medical Device Harmonised Regulation Model

    On January 1st 2016 the Agreement On the Common Principles and Rules of Circulation of Medical Devices in Eurasian Economic Union (EEU) officially came into force. Nevertheless, in practice, the common harmonised Eurasian system is still not working.

    During the year, the Eurasian Economic Commission (EEC) developed second-level regulations. At the end of the year, twelve out of thirteen legal documents were approved, including new approval (registration) rules for medical devices in the Eurasian Union. One of the most discussed of these second-level guidelines are the requirements for a quality management system for medical devices. Manufacturers are expected to implement mandatory quality audits for most medical device manufacturers for registration within the EEU in 2018.

    In addition to the second-level regulations in 2016, the EEC published twelve drafts of third level documents for the above mentioned agreement (e.g. list of voluntary standards, requirements for technical maintenance, recommendations for categorising borderline medical products, recommendations on the content and structure of the registration file). These have currently not been discussed.

    In November 2016, the Russian medical device trade association ― IMEDA ― together with the MedTech Europe Associations, held the Round Table “Common Market of Medical Devices: Supranational Regulation Model” in Moscow. Representatives of the EEC, together with European regulators, shared practices and discussed fundamental approaches to forming the common market of the MDs.

    According to the Agreement, today all member states of the Eurasian Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan) are in a transitional period. This Agreement allows  developing a Eurasian medical device regulation model, in parallel with local medical device regulations of the member states. This transition period is set to end in 2021.

  2. Russia Continues Clear Trend of Supporting Local Medical Device Manufacturers

    In 2016, the Russian government has continued its course on import substitution, which started as a “crisis management plan” in 2014.

    In December 2016, the Russian government published Resolution #1268 (link in Russian) and significantly extended the list of certain medical devices that originate from foreign manufacturers. This was initially implemented in February 2015 in the famous Resolution #102, which allowed the rejection of applications for tenders of foreign manufacturers of medical devices on the list in case if two (or more) similar products manufactured in Russia, Belarus or Kazakhstan were proposed. However, in practice, Russian device manufacturers included in the list had to obtain a special ST-1 certificate (not a simple process), in order to prove their products belonged in a “local” category.

    Another measure intended to help develop the Russian assembly of complex medical equipment is the amendment of the Russian Tax code. This was implemented in October 2016. It provided support to Russian medical device manufacturers, exempting them from paying value added tax (VAT) for the importation of components and raw material for the manufacturing process in Russia.

    Another example is a message from the Russian Federal Antimonopoly Service published in September 2016. They raised a sensible topic for foreign manufacturers of in-vitro diagnostics (IVD) systems and started the discussion to replace “closed” IVD systems with open ones.

  3. Regulation of Implantable Medical Devices is Continuing to Develop

    Price regulations of implantable medical devices ― an initiative that started in 2015 ― had a number of updates in 2016:

    In January 2016, the Russian government published Resolution #1517 (link in Russian) titled “On state regulations of prices of medical devices included in the list”, which set the methodology for how mark-ups on such devices should be calculated.

    Since February 2016, the Russian medical device regulator Roszdravnadzor has started requesting from manufacturers of implantable medical devices and Russian authorised representatives information about weighted average prices for their products. This uses a newly created electronic database.

    In July 2016, the Russian Ministry of Health published guidelines for determining the maximum amount of wholesale mark-up on medical devices implanted in the human body.

    In August 2016, the Russian government postponed all deadlines stipulated by the Resolution No. 1517 for one year:

    -Deadline for registration of maximum sale prices of implantable devices: delayed until 15 July 2017.
    -Deadline for the establishment of the regional authorities of maximum wholesale mark-ups to the actual selling prices of the implantable medical devices: delayed until 1 September 2017.
    -Deadline for the proposals by the Russian Ministry of Health in collaboration with other concerned agencies requiring submissions of the government proposals on the agreed upon procedure of re-registration of maximum sale prices: delayed until 1 October 2017.

    In 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 (more than 360 in summary) and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).

  4. Development of Local Medical Device Regulations in Russia

    The Russian medical device registration process continues to perplex regulatory professionals due to lengthy review times and a high number of rejections. Here are some developments that took place in 2016:

    In July 2016 the Russian Ministry of Health published requirements for the technical documentation and instruction for the use (IFU) of medical devices. This clarifies the full list of the information required in the technical file and IFU for medical devices and in-vitro devices.

    In August 2016 the Russian Ministry of Health implemented a mandatory procedure for medical device manufacturers to submit amendments in the registration dossier for approved medical devices. This is in cases where technical documentation has been changed.

    In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes in key medical device regulations. These include simplification of the registration process for IVD products, mandatory safety reporting for high class risk medical devices, and the allowance of official consultancy from Russian medical device regulators. Currently amendments have not been approved; discussions are due to start at the beginning of 2017.

    Since August 2016 there has been vivid discussion about a possible extension of the deadline for the procedure of administrative replacements of “old” forms of the registration certificates; nevertheless as of end of the day the 29th December 2016, this suggestion has not been not approved.

  5. Development of Local Medical Device Regulations in Kazakhstan

    Compared to Russia, the medical device approval process in Kazakhstan remains quite predictable. However, several significant changes in the regulations in 2016 should be highlighted:

    Since mid-2016 the Order of Kazak Ministry of Health #421(link in Russian) came into force and introduced mandatory regular safety monitoring of medical device manufacturers and their authorised representatives in Kazakhstan. The regulator recommends submitting periodic safety reports that contain information about product incidences and corrective actions both in Kazakhstan and worldwide every three months. This should start from the date of the registration until no later than the tenth day of the month following the report period.

    Moreover, in November 2016, the Kazak government published Resolution # 634 (link in Russian) and among others changed the requirements and implemented restrictions for visual advertising of medical devices.

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That is it for 2016; I would like to thank everyone for following, supporting and contributing to this blog and professional group. I would like to wish you a very happy holiday season and New Year filled with peace, prosperity and great achievements!

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2016

 

Dear colleagues and group members, please find below my selection of highlights in terms of medical device regulations in Russia, for September:

 

  1. State Control over Medical Devices in Russia
    In September, Roszdravnadzor (the Russian medical device approval agency) published a release about the state control over the circulation of medical devices. According to the regulator, 85% of the medical devices [on the Russian market, checked and tested in the context of state control measures] do not meet the required quality and safety requirements. Recall that today’s Russian medical device regulations require a full correspondence of all characteristics (technical specifications, model and size ranges, labelling, software versions), with the data provided in the registration dossier, and in the case of discrepancies with which this data medical product can be considered as unregistered by the regulator.
    State control over the circulation of medical devices has been implemented in Russia since 2013 and includes the possibility of revisions / audits of medical device manufacturers, distributors and clinics by Roszdravnadzor (see full regulation in Russian). Since 2015, Russia has strengthened the responsibility for violations of medical device regulations and today we can see some of the first legal practices on this.

 

  1. Revised Version of Requirements for Technical Files and Instructions of Use for Medical Devices
    The Russian Ministry of Health published a revised version of the draft of requirements for the technical documentation and instruction for the use (IFU) of medical devices. The document clarifies the full list of the information required in the technical file and IFU for medical devices and in-vitro devices. As you probably know by experience and based on the feedback from Roszdravnadzor, discrepancies and lack of consistency or particular information regarding these documents are the most common reasons in registration delays today.
    An interesting innovation for Russia is that the draft regulation allows a shorter version of instructions for the use for medical devices of the I and IIA class (on the condition that such medical devices can be safely used). According to the document, it is also allowed to distribute electronic forms of instructions for use (on the website or on the screen of the medical devices)—in this case, the manufacturer must ensure that the consumer is informed about how to have access to the up to date version and about how to receive their paper version.
    #
  2. Tax Exemption for Foreign Medical Device Components
    A number of amendments to the Russian Tax Code, exempting Russian medical device manufacturers from paying value added tax (VAT) for importing components and raw material for the medical device manufacturer process in Russia, will come into force on the 1st of October 2016. Until that day, Russian medical device manufacturers are required to pay 18% VAT on any imported components for their products, which, in some cases, poses significant restrictions and impacts on the cost of the manufacturing process. New amendments grant VAT exemptions in situations whereas the imported medical device components or the raw materials have no Russian equivalents and in those cases when their intention for manufacturing a medical device is proven. According to experts, the amendments will help to develop the Russian assembly of complex medical equipment, but their implementation in practice may take some time.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, May 2016

Dear colleagues and group members,

Welcome to my monthly update on medical device regulations in Russia and countries of the Eurasian Economic Union (EEU). Here are my three highlights for May 2016:

 

  1. Development of the Eurasian Medical Device Regulations

In May 2016, the Eurasian commission published final approved versions of five second-level regulations (which were previously available as drafts) for the Agreement on Common Principles and Rules of Circulation of Medical Devices in the Eurasian Economic Union (EEU):

  • Essential principles and rules on the safety and effectiveness of medical devices (link in Russian) – this document was drawn up on the basis of similar GHTF guidance and provides general and fundamental design and manufacturing requirements on the safety, quality and performance of medical devices (MD) and in-vitro medical devices (IVD). In addition, this document provides common labelling requirements for MD and IVD within the Eurasian Economic Union
  • Rules on conducting technical testing for medical devices (link in Russian) and Rules on conducting clinical trials (link in Russian) provide guidance on conducting pre-submission testing and trials. Good news for IVD manufacturers – in contrast to the current Russian approval process, only clinical trials will be needed in the EEU (skipping the technical tests). Not so good news for implantable devices – full-scale clinical trials with patients’ involvement will be mandatory for their approval
  • Resolution on the EEU medical device mark (link in Russian) – this document provides detailed descriptions of new EAC (EEU) medical device symbols and procedures of EAC-marking for medical devices approved under the new harmonised approval process
  • Resolution on the formation and maintenance of the common medical devices information system (link in Russian), which describes procedures for the common Eurasian database of approved medical devices, clinical centres and laboratories accredited to conduct trials/testing and information on medical devices’ adverse reactions and safety field actions within the EEU.

In these ways, today the full Eurasian medical device regulatory model can be vizualized like this:
EEU 201605

Although currently the new EEU procedures do not work in practice, according to the Eurasian commission, a full-scale launch of the new harmonised system is expected in 2016.

 

  1. The Russian Ministry of Health is considering an extended list of Implantable Medical Devices
    The Russian Ministry of Health is preparing an extension of the “List of Implantable Medical Devices for Medical Aid Provided to Citizens under the Programme of State Guarantees of Free Medical Care“. According to information published in May 2016 (link in Russian), the Russian regulator reviewed 671 applications from medical device manufacturers and medical institutions, with positive decisions made on the majority of them.

    In this context, it should be recalled that the last version of the list (with 207 items) was published in December 2014. According to the Russian Ministry of Health, companies producing Implantable Medical Devices not included in the list will not able to participate in national healthcare programmes from 2017. According to current procedures, applications for inclusion in the list can be submitted to the Ministry of Health by 1st March each year.

 

  1. New Version of Guidelines for Expertise in Medical Devices
    A draft of new guidelines on the expertise in medical devices for procedures of registration was published in May 2016 (link in Russian). This document contains detailed descriptions of the expertise procedure, requirements on documentation format for registration and testing files, and unifies these requirements from two expert organisations. The document will replace the previous version of these guidelines (link in Russian) published in November 2013 and will be expected to come into force formally in the near future.

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