Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in February 2019

Dear colleagues,

This is my short selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union for the last month:

 

  1. Medical Device Identification Requirement Initiative in Russia

The Russian law No. 488 (link in Russian), enforced in December 2018, gave the Russian government the right to approve the lists of goods subject to mandatory labelling/marking with additional means of identification. The objective of this initiative is to counteract the turnover of counterfeit products on the market.
Before 2019, the product labelling/marking initiative worked in experimental mode involving fur products (since 2016), medical drugs (since February 2017), and alcohol and tobacco products (since 2018). This year, Russia is also planning to gradually introduce the requirement of mandatory identification labelling/marking on other types of goods.

On 7 February 2019, the Russian medical device regulator Roszdravnadzor reported that the draft document on mandatory marking of medical devices has been prepared by the regulator and will be published in the near future. According to the regulator, the new requirements have been prepared ‘in line with the latest international requirements and on analogy with UDI’ in order to ensure traceability and to adequately identify medical devices through their distribution and use in Russia.


  1. Multiple Changes in Medical Device Regulations in
    Kyrgyzstan

On 14 February 2019, the decree No. 311 of the Government of Kyrgyzstan ‘On certain aspects related to the registration of medical devices’ (link in Russian) came into force and introduced multiple changes in the medical device regulation in the country.

Thus, new local medical device registration rules (link in Russian) were implemented. According to the new rules, the medical device registration process takes up to 90 days and consists of a two-step examination: analytical expertise (this step is not required for medical devices approved in the European Union, Australia, Canada, Japan and USA) and specialised expertise completed with manufacturing site inspections in some cases.

In addition to the new registration rules, the enforced decree No. 311 accepts that classification of medical devices, as well as technical, biocompatibility testing and clinical trials for local registration, are conducted according to enforced Eurasian regulations.

Kyrgyzstan is a full-fledged member of the Eurasian Economic Union since 2015.

  1. IMDRF Meeting in Moscow

The fifteenth meeting of the International Forum of Regulators of Medical Devices (IMDRF), chaired by the Russian Federation, will take place on 18-21 March 2019 in Moscow for delegates from the medical devices manufacturing industry, research institutions, federal executive authorities, state institutions, foreign and international regulatory organisations. The open stakeholders forum will be held on 19 March 2019, with an agenda and registration details available on the IMDRF website and on the official web page of the event.

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Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2019

Dear colleagues,

This is a selection of the latest updates in medical device regulation across Russia and the Eurasian Union countries for January 2019.

  1. Eurasian regulations on quality management inspections

The regulation 106 with requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure came into force in March 2018. However, until today the list of organisations conducting these inspections have not been officially published. At the beginning of 2019, we can see the development in the regulations on this subject.

Thus, on 11 January 2019, the Eurasian Economic Commission (EEC) published a draft document ‘on the requirements for inspecting organisations with the authority to inspect manufacturers of medical devices’ (link in Russian).

Later, on 28 January 2018, two potential organisations appeared on this list: the Russian Ministry of Health published a draft document (link in Russian) suggesting that two Russian governmental bodies, Roszdravnadzor and Rosatom, perform QMS inspections of medical device manufacturers according to the EAEU requirements.

It should be also recalled that abovementioned regulation #106 set the end of the transition period and start of QMS inspections for the EAEU medical approval process as of March 2019.

  1. Some updates in local registration procedures for Russia and Belarus:

There were also some updates for local medical device regulation systems:

On 26 December 2018, the Russian medical device regulator Roszdravnadzor published ‘Methodological recommendations on the procedure for conducting an examination of the quality, efficacy and safety of medical products for state registration’ (link in Russian), approved by both expert organisations involved in the medical registration process. The document may be useful in understanding detailed requirements, national standards and templates of forms used for every step of the medical device examination process during registration in Russia.

Also, on 11 January 2019, the Ministry of Health of Belarus published a letter (link in Russian) clarifying timelines for the different steps of the medical device registration process, inspections and expertise in Belarus.

  1. Changes in tax regulations for medical devices in Russia and Kazakhstan 

On 19 January 2019, according to the law of the Republic of Kazakhstan №211, amendments to the tax code of Kazakhstan came into force, which exempted pharmaceutical products and medical devices from value added tax (VAT). In particular, medical devices, orthopaedic products and hearing equipment, as well as materials and components for their manufacture, are exempt from VAT according to the additionally approved list.

In parallel, on 17 January 2019, the Russian government published the draft regulation (list in Russian) on changes in the list of medical products (Resolution #1042) exempted from VAT. Compared to the current version, the new edition of the list is supplemented with multiple new medical devices classified with Russian OKPD-2 codes.

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, September 2018

 

Dear Colleagues,

Here is my usual monthly selection of news about developments in medical device regulations in Russia and countries of the Eurasian Economic Union for September 2018.

  1. Kazakhstan Changes the Rules for Registration Examination of Medical Devices

At the end of August 2018, order #347 of the Ministry of Health of Kazakhstan (link in Russian) came into force and implemented multiple amendments to the rules of examination (expertise) of medicines and medical devices for registration according to the local procedure. 

Order #347 provides updated requirements for the content of the registration dossier, samples for testing, and the procedure for conducting the examination for registration. The expertise process for registration of medical devices consists, as before, of three steps (validation of the registration documents, laboratory testing, and specialised expertise), which take up to 90 working days of real time for I and IIA class devices and up to 160 working days for IIb–III class devices.
In the new edition of the rules, we notice the harmonisation of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.
The new rules also stipulate the possibility of obtaining pre-registration consultancy from the expert organisation.
New requirements have been effective for all medical device submissions for registration and renewals in Kazakhstan since early September 2018.

  1. Russia: Guidelines on Software Registration

On 12 September 2018, Russian medical device regulator Roszdravnadzor published methodological recommendations (guidelines) on the procedure for assessment (expertise) of medical software for its registration as a medical device in Russia (link to the document in Russian).
The published document is intended to establish uniform approaches for the registration assessment of software as a  stand-alone medical device across institutions involved in the medical device registration process in Russia.
The guidelines contain a list of criteria for assigning software to medical devices depending on their intended use, principles for classification and determining the risk category, possible criteria for non-compliance during registration assessment, algorithms for assessment of technical documentation, and a list of national standards used for software evaluation.

  1. Russia to Chair IMDRF in 2019

Russia will replace China as IMDRF (International Medical Device Regulators Forum) chair in 2019; this was announced during the IMDRF meeting in Beijing, China where  the key topics for the next year were highlighted as Cybersecurity, Premarket Reviews, Personalized Device Regulatory Pathways. The upcoming IMDRF meeting in March 2019 was also announced by the Roszdravnadzor management during the industry meeting in September 2018.

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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.