Three Things You Should Know about Medical Device Regulations in Russia, January 2016

Dear Colleagues,

It is the end of the January and I am glad to deliver my monthly update on events in the Russian and Eurasian regulatory landscape.

  1. The Eurasian Market for Medical Devices Formally Came into Force

On 1 January 2016, Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan formally introduced a common market and regulatory system for medical devices within the Eurasian Economic Union (EEU). One of the final steps – ratification by Russian parliament – was completed by the end of January. Some (but not all) second-level regulations have now been officially published and are in force: e.g. new rules on post-market safety surveillance can be found on the website of Roszdravnadzor (the Russian medical device regulator).

From a practical standpoint, there is currently no information about how any regulatory step (testing, expertize, clinical trials, registration submission) should be conducted under the new Eurasian approach, and medical device competent authorities in member states continue to receive registration submissions and grant approvals using “old” local procedures. From 1-28 of January 2016, for instance, 166 medical device approvals were registered in the database of the competent authority in Russia, while 87 approvals were made in Kazakhstan and 149 in Belarus.

Roszdravnadzor has announced a full-day regulatory conference (with online broadcast) on 4 February 2016, where more details and guidance about Eurasian medical device integration are expected to be announced.

 

  1. Evolution of Price Regulation for Implantable Medical Devices in Russia

The subjects of price regulation for implantable medical devices and “destabilization of prices in the market” for state procurements have been discussed by Russian government institutions since the end of 2014, when the Russian Ministry of Health published a list of “implantable medical devices approved for state programmes of guarantees on gratuitous medical care”.
In March 2015, Russia adopted amendments to Article #80 of Federal Law No. 323-FZ (“On fundamental healthcare principles in the Russian Federation”) and introduced regulation of maximum sale prices and maximum volume of wholesale and retail mark-ups for medical devices on the previously published list.
On 9 January 2016, the Russian government published Resolution #1517 (link in Russian), titled “On state regulations of prices of medical devices included in the list”. The resolution came into force on 16 January 2016 and set the methodology for how mark-ups on such devices should be calculated. According to the resolution, prices in future state procurement contracts for implantable medical devices on the list cannot exceed the stated values, including after maximum mark-ups and valued added tax have been calculated accordingly.
In addition, the resolution set a deadline of 15 July 2016 for manufacturers or Russian-authorized representatives to submit files to Roszdravnadzor for price registration.

 

  1. Roszdravnadzor on Medical Software

Roszdravnadzor clarified its requirements for medical software. According to the letter released at the beginning of January (link in Russian), the Russian medical device regulator has informed manufacturers that medical software should be considered a type of medical device and must therefore pass the mandatory registration process if it has any of the following uses: operation of medical equipment, receiving diagnostic data, monitoring and transmitting information on bodily functions (including wireless technologies), calculating dosages for medicines or emissions, medical data management, medical image processing, 3D modelling, or connection of medical and diagnostic equipment. Medical software in Russia, like in many jurisdictions, can be registered as a standalone unit or an integrated part of a medical device.

 

To conclude, I would like to remind that you can follow my updates about Russian medical device regulations on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, November 2015

Is it the calm before the storm? In November 2015 we cannot observe major regulatory news and updates for medical devices in Russia and the Eurasian Economic Union countries… In one month’s time the common harmonised market of pharmaceuticals and medical devices will begin functioning (at least formally). Meanwhile, at the current time, there are still a lot of questions to be answered, second-level regulations and guidelines to be published…
Nevertheless, here are some updates which should be useful to know for your Russian regulatory projects:

  1. New version of national standards for labelling requirements for In Vitro devices

In November 2015 the Russian Federal Agency on Technical Regulating and Metrology (Rosstandart) published an updated version of its voluntary national standard GOST R ISO 18133, which is composed of five parts and which contains technical requirements on labelling and accompanying information and documentation for In Vitro Diagnostic (IVD) medical devices (part 1, link in Russian), IVD reagents (part 2, link in Russian), IVD instruments for professional use (part 3, link in Russian), self-testing IVD devices (part 4, link in Russian), and IVD instruments for self-testing (part 5, link in Russian). The new standard will come into force in November 2016 and will replace the version from 2009, which is valid currently. It should be recalled that the use of standards is voluntary, but recommended by Roszdravnadzor as the best way to demonstrate that a medical device meets all labelling requirements during the approval process and into further commercialisation.

  1. Discussions around the Russian product classification code

FullSizeRenderAnother update from the Federal Agency on Technical Regulating and Metrology (Rosstandart) is the extension of validity of the Russian product classification code OKP (ОКП ) until 1 January 2017. The OKP code is a classification code which is present in every registration certificate (in addition to the medical device safety class and nomenclature classification) and is used by customs officials, among others, to define the amount of VAT exemption during medical device import and customs clearance. Previously, the deadline for transition into a new product classification system was set as 1 January 2016, which seemed to threaten a wave of uncertainty in calculation and in applying VAT exemption in practice. It should also be noted that some months ago Roszdravnadzor (the Russian medical device regulator) expressed the opinion that, in future, this code should be removed from the registration certificate.

 

  1. Armenia joins the EEU Agreement for Medical Devices

ArmeniaArmenia ratified the Agreement on common principles and rules of circulations of medical devices signed at the end of last year by EEU countries. In such a way, for November 2015, this agreement is approved by Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia. It should be noted that, at present, unlike in other EEU countries, Armenia regulates the approval process for pharmaceuticals and not medical devices, which suggests quite deep further changes are coming in the medical device sector for the country.

In conclusion, I would like to thank you for the following and remind that you can get regulatory updates about Russian medical device regulations from this blog directly in your e-mail using the ‘Follow’ button in the toolbar in the upper corner of this page.

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

Dear colleagues,

Welcome to my monthly update, in which I share the latest news and updates on medical device regulations in Russia and countries of the Eurasian Economic Union (EEU). Here are my three highlights for October.

 1. The Russian government approved the list of medical products subject to value-added tax exemption.

In the first days of October 2015, the Russian government published resolution #1042 (link in Russian) and approved the list of medical products, which are not subject to value-added tax (VAT). The list consists of three parts: medical devices, optical devices and rehabilitation equipment. Resolution #1042 placed the period in long-lived contradictions between tax and customs legislation for medical devices in Russia. According to article 150 of the Russian Tax Code, imports of medical devices to Russia should be exempted from VAT. However, for several years this rule was a source of controversy for Russian customs, which imposed extra VAT (18% instead of 0%) in some cases due to new terminology for medical devices implemented by the Federal Law #323 in January 2013.

  1. Kazakhstan implemented new fees for the registration of medical devices.

On 22 October 2015, the Ministry of Health of Kazakhstan enforced resolution #771 (link in Russian), implementing new rules for the calculation of fees for the expertise of medical devices for the state registration. New fees are provided for different classes of medical devices and are calculated based on safety class and number of modifications of the device or number of units in the kit in one submission. For example, the minimal fee provided for registration of a simple, low safety class medical device for dentistry is calculated as 48,000 KZT (about 170 USD) per unit; the highest fee of 515,000 KZT (about 2,000 USD) is provided for complex capital equipment.

  1. Eurasian medical device session of the National Annual Regulatory Conference.

Less than two months remain until the enforcement of the Agreement on common principles and rules of the circulation of medical products of the Eurasian Economic Union. A special session of the Annual National Regulatory Conference, FarmMedObrashenie, was devoted to this topic on 19 October 2015, where a representative from the Eurasian Economic Commission made a report on the status of second-level regulations to this agreement. It was reported that no final regulations have yet been published and all documents (thirteen in total) are currently still in ‘a high state of readiness’. All drafts are available online. Possible changes ‘will be of an administrative nature’ only and the final regulations are stated to be enforced ‘in very similar editions’.
Representatives from Roszdravnadzor (Russian medical device regulator) expect that ‘in order to avoid a repetition of the painful Russian experience of 2013’, with high probability during the transitional period imposed in chapter 11 of the Agreement, it will be possible to work on two parallel procedures: the local registration procedure of the country (effective today) and a new procedure of the Eurasian Union. Please see detailed Q&A on this topic in the separate post.

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 You can also follow me on twitter @MedDevRus.

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

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

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).

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

Dear Regulatory Colleagues,

Please find below my monthly update of important news on medical device regulations in Russia and the CIS region:

1.Ukraine: The Transformation of the Medical Device Regulatory System – Will it be Painful for the Industry?

1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this, new products will only be able to access the Ukrainian market by conforming to assessment procedures similar to those used by the European regulatory model. The Ukrainian Ministry of Health should promptly adopt additional regulations for the transition to the new regulatory system. It should be remembered that the introduction of new regulations has already been postponed three times in the last several years. Industry players consistently express fears about a possible crisis in the medical device sector in the country due to incomplete legislation covering the transitional period. Another concern of local trade associations is the introduction of mandatory inspection for foreign medical device manufacturers as a part of the assessment procedures for certain types of device. This has a high probability of causing extra delays in market approval due to the lack of qualified inspectors.

2. Russia: Revised Standards on Clinical Trials

A new Russian national standard (GOST ISO 14155-2014 “Clinical trials: Good Clinical Practice” – link in Russian) came into force on 1 June 2015 and replaced the previously enacted GOST R ISO 14155-1-2008 and GOST R ISO 14155-2-2008 standards. This standard has been designed to harmonize with the similar international standard ISO 14155: 2011, which addresses planning, documentation and proper representation of the results of clinical trials to ensure the validity of the data, as well as to protect the rights, safety and well-being of human subjects and define the responsibility of sponsors. It should be highlighted that this standard is highly recommended by Roszdravnadzor (Russian medical device regulator) for clinical trials related to the registration of medical devices in Russia, and it is not applicable to in-vitro diagnostic devices.

3.Eurasian Union: Draft of Harmonized Technical Testing Rules

As is commonly known, the requirements of the technical testing (a form of conformity assessment) for medical devices, as well as requirements for laboratory accreditation, currently differ between Russia, Belarus and Kazakhstan. This means that the results of tests conducted in any one of these countries are not recognized or accepted in the others. On 22 June 2015 the Eurasian commission published a draft of harmonized rules (link in Russian) for technical testing of medical devices, establishing common requirements for technical test procedures across the Eurasian Economic Union (EEU). This document is a second-level guideline which (together with other second level regulations) complement the agreement on the common principles of the circulation of medical devices (link in Russian), which are expected to come into force on 1 January 2016 and thenceforth govern a common market for medical devices in the EEU.

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As usual, I would also like to remind you that the objective of this blog is to make Russian and Eurasian medical device regulations clearer. I therefore encourage you to post your comments and questions either here or on the Russian medical device regulations LinkedIn group.

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

Dear Colleagues,

I hope your Russian regulatory projects are going well! Let me deliver my monthly update of the most important regulatory news for Russia, CIS and the Eurasian Customs Union:

  1. Ukraine: should current medical device registration certificates be renewed?

1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this date, the access of new products to the Ukrainian market is expected to be possible only by obtaining a special mark, achieved by conformity with the new technical regulations such as:
-technical regulation #753 –        Medical devices (link in Russian)
-technical regulation #754 –        In vitro diagnostic devices (link in Russian)
-technical regulation #755 –        Active implantable medical devices (link in Russian)
The deadlines for mandatory application of technical regulations has been repeatedly postponed since  2011, but according to the message from the Ukrainian Ministry of Health, this year the Regulator is going to adhere firmly to the announced date and does not recommended another postponement.
Last month the Ukrainian government approved decree №181 (link in Russian), which establishes a procedure for the transitional period until 1 July 2015. After 1 July 2015, the admission of products already registered in Ukraine is expected to be permitted until 1 July 2016 or until the expiration date of the relevant product’s registration (if this date is earlier than 1 July 2016).
Meanwhile, Ukraine has recently established a temporary exemption from VAT and fast track registration for certain medical devices imported and/or supplied on the basis of agreements with qualified international procurement agencies.

  1. Strengthening price regulation for implantable devices in Russia

Amendments to the Federal Healthcare Act (link in Russian), signed in February, are aimed at strengthening the regulation of prices for implantable medical devices. These amendments officially came into force on 9 May 2015. These amendments have introduced price registration, monitoring and control for implantable medical devices included in the list of implantable medical devices subject for national reimbursement programmes.  Despite the fact that these amendments are now in force, the law is not yet effective due to a lack of secondary legislation (i.e. a description of  the price registration procedure and  methodology for determining the maximum wholesale producer’s prices for medical devices) which are at the stage of approval and are expected within the coming weeks.

  1. Status of the Eurasian Medical Device Harmonisation

At the meetings of the working group of the Eurasian Economic Union (13-15 May 2015 in Almay (Kazakhstan)) it was confirmed that there may be a “high degree of readiness” of a major part of second-level regulations for common medical device regulations, which is expected to come into force on 1 January 2016. The draft rules of registration and expertise of medical devices proposed previously by Kazak regulators as well as the requirements for its implementation maintain the quality management system for medical device manufacturers are approved with some additional recommendations.  Documents will be available on the official website. For now, three guidelines for new medical device systems are already approved and available: 1. classification according to safety class (link in Russian), 2. essential principles of safety and performance (link in Russian) and 3. requirements for EAC mark (link in Russian).

Let me take advantage of this update as well to thank you for following this blog and invite you again to register and to ask your questions in the new Russian Medical Device Internet Forum which you can find at the top of this page //www.medicaldevicesinrussia.com/ or http://meddevrus.listbb.ru

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

As usual at the end of the month, I would like to share my selection of highlights on what is going on with the regulation of medical devices in Russia, the Eurasian Customs Union, and CIS countries:

 

  1. Russia has published a 5-year import substitution strategy.
    The Ministry of Industry and Trade of the Russian Federation (MinPromTorg) approved the 2nd April 2015 strategic 5-year plan for import substitution in the pharmaceutical and medical device industry. Within this plan, there is a list (link in Russian) of one hundred and eleven groups of medical devices detailing targeted market shares of foreign manufacturers by 2020. Among them, for example, are surgical disposable materials (target is 40% imports in 2020, compared to 90% at the moment), prostheses, endoprostheses and their parts, cardio pacemakers (10% import in 2020 vs. 85% now), endoscopes (35% vs. 100%), X-ray equipment, and other groups of medical devices. It is to be noted here that the National program for the development of the pharmaceutical and medical industry approved last year’s target of a 40% market share of all medical devices to be manufactured in Russia by 2020.
  2. Kazakhstan has changed the registration procedures.
    In April, the Ministry of Health of Kazakhstan published changes in order №735 of the registration of medicines and medical devices and medical technique equipment (link in Russian) and order №736 for expertise in pharmaceuticals and medical devices (link in Russian). The relevant authorities in Kazakhstan held a seminar explaining the new rules.
    The main changes in procedure include a requirement of expertise of a medical device prior to a submission for registration and introduction of a mandatory electronic registration dossier.
    From April 2015, all registration documents will only be accepted in electronic form. In the process for expertise and registration, the electronic dossier will be updated with the conclusions of experts at all stages of examination, as well as with additional materials. It should be recalled that Kazakhstan has a separate procedure for medical equipment (technique) and medical devices and requires separate registration for every manufacturing site.
  3. Medical device mark for Eurasian Economic Customs Union.
    In April 2015, the draft ( link in Russian) of a special mark for medical devices marketed in the Eurasian Economic Customs Union (EECU) became available on the website of the Eurasian Economic Commission.Screenshot_1
    It is expected that before the release of a medical device for circulation in the EECU, the manufacturer or their authorised representative will mark the medical device with this mark (the device, individual packing, and instructions for use should be marked), if the device passed the newly established registration procedure. Let me remind you that the agreement on common principles of the circulation of medical devices, signed in December 2014, implies the harmonisation of registration and labelling requirements, circulation, and post-market surveillance for medical devices across Russia, Belarus, and Kazakhstan from the 1st January 2016.

I would also like to use the opportunity of this update to thank all blog readers and group members for following and invite you to join my presentation on upcoming EECU medical device regulations at the Informa Regulatory Affairs in Emerging Markets conference in June 2015.

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

It is time for a monthly update and here are the most important medical device regulatory initiatives and changes for Russia, the Eurasian Customs Union (ECU) and the CIS region for March:

1. Russia: Price Regulation for Implantable Medical Devices for State Procurements

On 9 March 2015 the Russian president signed an amendment (link in Russian) to article #80 of the Russian Federal Law #323 “On the Fundamentals of Health Protection in the Russian Federation”. These amendments introduce additional price regulations for implantable medical devices included in the recently approved list of implantable medical devices subject for national reimbursement programmes. Roszdravnadzor (a Russian medical device regulator) launched a website for the weekly monitoring of price dynamics for implantable medical devices. The regulator is expected to be responsible for the registration of manufacturers’ maximum sales prices, maximum wholesale and retail mark-ups and the maintenance of the national open public register with this information. The draft of the detailed guidance for this initiative (the methodology for determining the maximum wholesale producer prices for medical devices) will be available (link in Russian) for public discussion by 19 April 2015 on the official online database of the federal executive authority and is expected to come into force within Q2 2015.

2. Eurasian Customs Union: End of the Transition Period for EAC Conformity Assessment Procedures
15 March 2015 was the day when the transition period for several technical regulations of the ECU ended, among them TR TS 020/2011 “Electromagnetic compatibility” (link in Russian) and TR TS 004/2011 “On safety of low voltage equipment” (link in Russian). Since 15 March 2015, manufacturers and importers who release into circulation on the ECU market products (including medical devices) covered by these technical regulations will have to undergo a new conformity assessment procedure (an EAC procedure according to the requirements of the ECU technical regulations above instead of the GOST-R assessment procedure in Russia).

3. Ukraine: Simplified Registration Track for Certain Medical Products
On 19 March 2015 the Ukrainian Parliament approved Law #2150 (link in Ukrainian). This law provides a separate temporary mechanism to engage specialised international organisations and funds (among them the International Dispensary Association, Crown Agents, Partnership for Supply Chain Management, and others) in the procurement of certain medicines and medical devices on the basis of a special agreement with the Ukrainian Ministry of Health. The law introduces a simplified and fast-track (up to 14 days) registration procedure for certain medicines and medical devices that are to be procured by these organisations and allows them to be classified as essential medical products for subsequent release from additional import duty.

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

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

As usual at the end of the month, I would like to share my vision for the main features of a regulatory landscape in the medical device sector in Russia. Here is my selection of highlights for February:

  1. Russia implemented restrictions in the medical device sector

On 6 February 2015, the Russian government implemented restrictions for admission to state tenders for certain types of medical devices. This measure was taken as a part of the initiative supporting the ‘import replacement’ program and ‘promoting the development of domestic manufacturing of medical devices’. According to expert assessments, the share of foreign medical devices in some sectors of Russian state procurements reaches up to 85%. According to the published Decree #102 (link in Russian), which contains a list ‘of certain types of medical devices [45 items] originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’, applications to tender for state and municipal procurements will be denied for foreign manufacturers of medical devices if there are two or more entries from Russia Belarus, Armenia, and Kazakhstan. It should be pointed out that this initiative has been discussed since 2012 and that the restrictions implemented by the decree are relatively softer than those in the previous circulated draft.

  1. Development of Eurasian Medical Device Regulatory Guidelines

The Eurasian Economic Commission is currently developing subordinate acts (second-level guidelines) to implement the strategic agreement on common principles and rules of circulation for medical devices in the Eurasian economic space signed in December 2014. More than ten legal acts addressing medical devices are expected in 2015, but for the moment, only one of them (guidelines to define a safety class for medical and in-vitro devices) has been agreed upon and accepted. The list of Essential Principles of Safety and Performance of Medical Devices (harmonised with GHTF/SG1/N68:2012) and common marking, labelling, and testing requirements are currently under discussion by a working group and may be agreed upon and published in Q2 2015. The common Eurasian medical device registration rules proposed by Kazakhstan and duplicating the existing Kazak medical device approval model is the most active discussion topic among regulators and the medical device industry. Meanwhile, all three regulators (Russian, Belorussian, and Kazak) are consistent in their message that, even though there is a large number of guidelines to accept in a short period, the new system will go into effect in January 2016 and replace current national regulations.

  1. Evolution of Implantable Device Regulations in Russia


1 March is the deadline set by the Russian Ministry of Health to submit proposals for the list of implantable medical devices subject to state reimbursement programmes for 2015. According to the regulator, the list will be reassessed annually, and all proposals submitted after this date could be considered for inclusion in 2016. The current version of the list was published in December 2014 and now contains 205 types of implantable devices grouped based on the recently implemented Russian medical device classification. In parallel, the Russian government set a target date of Q3 2015 to develop and implement a legal mechanism under which medical devices included in the list will undergo price regulation and monitoring to participate in national reimbursement programmes.

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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.