Russian and Eurasian Medical Device Regulatory Recap 2018

Dear colleagues,

In my December newsletter I would like to summarise all the major changes in medical device regulations and trends in Russia over the past year. So here are the top stories you should know in 2018 if you deal with medical devices in Russia.

  1. The development of the Eurasian medical device regulation model has been the most important topic for several years now.

    In March 2018, the last «second level» regulation, #106, of the Eurasian Economic Commission (EEC) on the requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into force and was postponed for one year to allow for a transition period. These requirements were developed on the basis of international standard ISO 13485; however, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with the requirements of the ISO standard itself.

    Over the year 2018 the EEC released multiple «third level» medical device regulations:

    -Recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within EAEU regulations (link to the document in Russian).

    – Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials for medical devices in the EAEU.

    – Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate.

    – Methodical guidelines exist for medical device registration expertise for EAEU registration (link in Russian).

    – Regulation #25 concerns the criteria for classifying products as medical devices in the EAU (link in Russian).

    – Regulation #176 concerns the single register of organisations conducting testing/trials for medical devices for registration in the EAEU (link in Russian).

    – Regulation #177 provides a single database on the safety monitoring of medical devices in the EAEU (link in Russian).

    English translations of most Eurasian medical device documents are available on the official EEC website.

    In November 2018, the EEC announced that the first applications to register medical devices under the EAEU medical device system have been filed for review by the competent authorities in Kazakhstan and Russia.

    Over the last year there has been a great deal of discussion on the level of competency of the competent authorities and in the media about potential prolongation of the transition period for the EAEU medical device registration system. There is a draft document available for the end of the year 2018, but no official position has been released on this topic and the end of the transition period remains as 31 December 2021.

  2. Changes and initiatives in the local regulatory systems in Russia and Kazakstan occurred over the year 2018 in parallel with the development of the EAEU medical device system.

    – In June 2018, the Russian government released Resolution # 633 (link in Russian) and simplified the registration process for in-vitro diagnostics in Russia, implementing a one-step assessment process (instead of a two-step process, as previously followed) for all classes of IVDs, which has shortened the overall approval process for IVDs by up to several months.

    – Likewise, Resolution # 633 (link in Russian) implements improvements for the registration of medical devices with a pharmaceutical component (which was considered a significant roadblock in the approval of such medical devices in Russia) before.

    – Another important initiative for Russia (which has not been approved by the end of 2018) is to suggest an expansion of the list of cases when clinical trials involving human subjects are required for the approval of medical devices. The draft document published in May 2018 introduces a requirement for all medical devices  IIB and III classes to undergo mandatory clinical trials involving human subjects, which should be conducted in at least two medical organisations following a single clinical trials protocol.

    – In August 2018, the Ministry of Health of Kazakhstan implemented multiple amendments to the rules for examining (expertise) medicines and medical devices.The published order, #347, (link in Russian) provides the updated requirements for the content of the registration dossier, samples for testing, the procedure for conducting the examination for the registration, and harmonising of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.

  1. Russia chairs the IMDRF in 2019

In conclusion, it should be especially highlighted that in 2019 Russia will be the chairman of the IMDRF and the next two meetings of the IMDRF will be held in Russia: in March 2019 in Moscow and in September 2019 in Yekaterinburg.
The key topics for the meetings for the next year were highlighted as cybersecurity, premarket reviews, and personalised device regulatory pathways.

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This was the Russian medical device regulatory landscape in 2018.
I would like to thank everyone for following, supporting, and contributing to this blog, my non-commercial project to make Russian and Eurasian medical device regulations clearer for regulatory professionals worldwide.
I would like to wish you a wonderful holiday season!

See you in 2019; there are many exiting things to come.

Alexey Stepanov

Alexey@medicaldevicesinrussia.com

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 and the Eurasian Union, August 2018

Dear Colleagues,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia and the Eurasian Union for August 2018.

1. Potential Changes in the Eurasian Medical Device Transition Period for certain group of devices

On 6 August 2018, the Eurasian Commission published a draft regulation (link in Russian) that suggests prolongation of the validity of the medical device registration certificates of Eurasian member states for certain group of devices after the end of the Eurasian transition period.
According to Article 11 of the Agreement on the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (signed on 23 December 2014 and enforced on 12 February 2016), registration certificates issued by member states prior to the date of enforcement of the agreement are valid no later than the end of the transition period set as 31 December 2021.
The published draft proposes that medical devices registered by Eurasian member states after the date of the enforcement of the Agreement may be in circulation in that member state until the expiration date of the registration documents.
Thus, in case of approval, this document will allow the Eurasian registration deadline of 31 December 2021 for medical devices registered in Russia and other member states after 12 February 2016 to be disregarded.

2. Memorandum of Understanding on Medical Device Nomenclature

Another interesting update on the development of Eurasian medical device regulations is the draft memorandum (link in Russian) of understanding between the Eurasian Economic Commission (EEC) and the Global Medical Device Nomenclature Agency (GMDN), published by the EEC on 21 August 2018. This document publicises the collaboration and exchange of information between the two agencies with the objective of harmonisation and actualisation of Eurasian and GMDN nomenclature.
You will recall that several regulations on Eurasian medical device nomenclature classification have already been adopted and enforced: Eurasian regulation #177 (link in Russian), adopted in 2015, and Eurasian regulation #46 (link in Russian), adopted in April 2018.

3. Update on the Russian Standard for Medical Device Ethylene Oxide Sterilisation Requirements 

On 1 September 2018, the new version of the Russian national standard GOST ISO 11135-2017 ‘Sterilisation of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilisation process for medical devices’ (Link in Russian) will replace the old version (GOST ISO 11135-2012). The new version of the GOST standard is  identical to the international EN ISO 11135:2014 and sets out how to ensure that medical devices are sterilised effectively, using an ethylene oxide sterilisation process. The new version of the Russian standard should be considered during pre-registration testing, and files submitted for registration after the date of enforcement.

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

 

Dear colleagues,

This is a monthly update with my selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union.

1. The Eurasian Union: New Third-level Regulations Adopted

On 24 July 2018, the Eurasian Commission adopted and released two new third-level documents entailing Eurasian medical device regulations:

  • Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials of medical devices in the Eurasian Union;
  • Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate. The suggested criteria (e.g. dimension types, group specifications, or same analytes for in-vitro diagnostics) are applicable on the condition that the modifications to the medical device have the same safety/risk and Eurasian nomenclature classifications.

In addition to the documents released in May 2018 and September 2017, so far, six third-level Eurasian medical device regulations have been adopted overall.

2. Russia: Extension of the Restriction List (Draft)

On 24 July 2018, the Russian Ministry of Industry and Trade published a draft regulation (link in Russian) proposing a further expansion of the list that imposes restrictions on state purchases of medical devices from foreign manufacturers in favour of domestic manufacturers, according to Resolution #102. The published document proposed including six new types of medical devices in the restriction list: medical functional beds, concentrates for haemodialysis, tonometers for intraocular pressure, air sterilizers, dry air thermostats, and otorinoscopes.
Resolution #102 was introduced in February 2015 as a measure to support the “import replacement” programme and to promote the development of the domestic manufacturing of medical devices; since this time, the restriction list has been extended several times, in 2016 and 2017.

3. Russia: Updating Medical Device Inspection Checklists (Draft)

On 6 July 2018, the Russian medical device regulator Roszdavnadzor published a draft document (link in Russian) with amendments to the content of the check-lists used for routine inspections of medical devices manufacturers by the regulatory agency. The published draft document proposed removing from the checklist several questions concerning the use of the Russian language on external labelling and instructions for the use of the medical devices. Amendments to this document are due, given that Decree No. 1037 regulating the language requirements for non-food products in Russia was repealed in March 2018.
However, the removal of the questions about the Russian language from the check-list does not mean the repeal of the requirement for the use of Russian on external labelling and instructions for use for medical devices in Russia, which is currently regulated by other Russian and Eurasian documents.

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

 

Dear fellow colleagues,

This is a monthly update with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union for June 2018.

  1.       Russia: Simplification of the Registration of IVD Products and Other Multiple Changes in Medical Device Registration Rules

During the first few days of June 2018, the Russian government released resolution # 633 (link in Russian) and enforced the long-awaited multiple changes in the Russian medical device registration rules.

The enforced changes have a most significant impact on the procedure for the registration of IVD products. Henceforward, all classes of IVDs pass through a one-step assessment process (instead of a two-step assessment process, as previously followed), eliminating several months of the assessment phase in obtaining authorisation for clinical trials. From now on, mandatory local clinical trials for diagnostics may be conducted in parallel with technical assessment before submission to the Russian competent authority, Roszdravnadzor. This may, hopefully, shorten the overall challenging approval process for IVDs in Russia by up to several months.

Another significant change affects the registration of medical devices with a pharmaceutical component. The resolution released replaced the requirement for the mandatory registration of the drug component as a pharmaceutical substance in Russia (which was considered a significant roadblock in the approval of such medical devices in Russia) by a new requirement to provide confirmation of the quality of the drug component according to the regulations in the country of its origin.

The enforced changes will also affect the procedure for registration renewals (amendments of the registration certificates and amendments of documents of the registration dossier), introducing classification of the registration renewals depending on the product/design changes.

Some other minor changes in the registration procedure and timelines overall were aimed at simplifying the IVD and medical device  approval process and making registration requirements similar to upcoming Eurasian medical device registration rules.

2.       Eurasian Economic Union: Updated Criteria for Borderline Products

On 22 June 2018, the Eurasian commission published an updated version of the draft of recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within the terms of Eurasian medical device regulations (link to the document in Russian).

The document provides guidance for how to classify products as medical devices, in-vitro devices, cosmetic/toiletry products, disinfectants, general purpose products, assistive/rehabilitation products, products for sports or leisure, personal protective equipment, medical software, medical packaging, physiotherapy devices, medical furniture, medicinal products and medical devices with a drug component and some other products depending on their intended use.
These criteria can be used in the preparation of documents for the registration of medical devices and also in the examination of the effectiveness of medical devices in accordance with these rules.

3. Kazakhstan: New List of Medical Products Exempt from VAT

On 15 June 2018, the Ministry of Health of Kazakhstan, according to its resolution #124, enforced the new list of medical products (pharmaceutical products and medical devices) for which the selling and importing are exempt from value added tax (VAT).
The new list is available online (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, April 2018

Dear Colleagues,

This is an update for April with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union countries.

  1. Statistics on Medical Devices in Russia in 2017

At the beginning of April 2018, Russian medical device regulator Roszdravnadzor announced statistics and published a detailed report on approvals of medical devices and post-market control for 2017. It detailed about 1403 new medical devices approved in the last year. It should be noted that, compared to previous years, this amount showed a decrease for the first time since 2014.
The published report (link in Russian) also mentions a significant increase of registration rejections in the last year (647 rejections in 2017 against 477 in 2016), caused, according to the regula

tor, by “among other factors, enforcement of Order 11N on requirements on technical file and instruction for use for registration” in March 2017.

Roszdravnadzor also reports positive decisions to amend 3548 registration certificates and 570 registration dossiers in 2017. The total number of files submitted to the agency by medical

device companies was reported as 5262.
Regarding post-market control, the regulator reports about 5124 inspections and 827 examinations (expertises) of medical devices approved on the market which in 89.5 % cases revealed non-conformities of the examined medical devices with current Russian regulations.89,5.png

  1. Price Regulations for State Procurements of Medical Devices in Kazakhstan

At the end of March 2018, the Ministry of Health of Kazakhstan enforced Order #112 (link in Russian) and updated requirements on the registration of prices for medicines and medical devices for state procurements within the guaranteed free medical care. According to the document, medicines and medical devices may be purchased at prices not exceeding those established by the competent authority. The requirement is applicable for purchases by government institutions within the guaranteed free medical care or using health insurance funds.
Updated rules and guidelines for price and mark-up registrations have been published previously (link in Russian). Prices may be submitted online and should be registered by the competent authority within ten working days. The deadline for submission of information on prices was set as 27 April 2018 by the competent Kazakhstan authority (National Centre of Expertise).

  1. Several Eurasian Medical Device Regulations Approved

There was no breakthrough in start of functioning of Eurasian medical device regulations model in April 2018 compared to previous month; however, the Eurasian Commission approved several “third-level” regulations which come into force in May 2018:

-Regulation #46 on nomenclature of medical devices in EAEU (link in Russian);
-Regulation #47 on classification on adverse events for medical devices (link in Russian);
-Regulation #48 on classification of documents of the registration dossier (link in Russian).

In addition, one other interesting and detailed document published in April 2018 is the draft of the updated guidelines/recommendations for the expertise of medical devices for registration according to Eurasian requirements (link in Russian); however, as of the end of April 2018 the final approved version of the document is not available.

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