Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union – June 2019

 

Dear colleagues,

Welcome to my usual monthly review containing the most important medical device regulation changes across Russia and the Eurasian Union over the past month:

  1. New Restrictions on State Procurements for Certain Medical Devices in Russia

On 26 June 2019, the Russian government published Resolution # №813 (link in Russian) and extended the list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. 

The state procurement of medical devices included in the list, according to the Resolution #102 introduced in 2015, will be closed to foreign manufacturers if at least two bids on medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted for tender.

Above-mentioned Resolution # №813 has added 14 new types of device to the restriction list including ventilation devices, gamma-therapeutic radiation complex, ultrasound devices, certain types of endoprosthesis, external fixation devices, medical beds, intraocular lenses, intraocular tonometry, micro sources with iodine-125, certain adhesive dressings and surgical materials, medical devices for storage and transporting biological samples, air sterilisers and dry air thermostats.

According to the published document, analogs of each of these products are currently produced in Russia in sufficient volume by at least two local companies. The decision was taken with the aim of supporting the development and production of these products in Russia.

The new revision of the list is available in Russian.

  1. Russian Ministry of Health Clarified Trademark Requirements for Medical Device Registration 

The requirement to provide confirmation of the legitimate use of the Russian trademark for registration of a a medical device is a relatively new requirement, which was introduced by the Resolution 633 in June 2018 and raised a lot of questions and confusion across registration applicants over the last year.

Thus, according to the petition initiated by Russian medical device registration consulting company Medrelis and 28 medical device companies submitted to the Russian Ministry of Health in May 2019, over the past year the interpretation of trademark legitimacy by Russian health care regulator Roszdravnadzor was often controversial and led to additional difficulties in the registration procedure and an increased amount of registration rejections.

On June 2019, the Russian ministry of health, for the first time since the enforcement of the new trademark requirements, clarified (the letter kindly provided by Medrelis) that Roszdravnadzor, to prevent the circulation of counterfeit medical devices, may compare (verify) information provided <for registration of a medical device> by the manufacturer or the authorised representative of the manufacturer (s) with information received, inter alia, as “interdepartmental information interaction” (which means that missing documents confirming trademark legitimacy in the registration file may not be a reason for the registration rejection or additional requests to the applicant from the regulator).

  1. Multiple Updates of Regulations for Medical Devices and Pharmaceuticals in Kazakhstan

Kazakhstan continues to release multiple updates to local medical device and pharmaceutical regulations started earlier this year. Thus, for the past months the following regulations have been released in new revisions: 

  • On 02 May 2019 – the order KR-DCM 53 (Link In Russian) updating the rules of wholesale and retail sales of medicines and medical devices.
  • On 27 May 2019 – Order KR-DCM-88 (Link in Russian) updating pharmacovigilance requirements for pharmaceuticals and rules for safety monitoring of medical devices; 
  • On 7 June 2019 –the Order KR – DCM 82 (Link in Russian) updating requirement rules for assessing the safety and quality of medicines and medical devices registered in Kazakhstan;
  • On 9 June 2019 – the Order KR – DCM 87 (Link in Russian) updating rules of state registration, re-registration and amendments of the registration dossier for pharmaceutical products and medical devices.

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

 

Dear Colleagues,

In my regular post, let me share information on the main developments and changes of medical device regulations in the Russian and Eurasian regions over the past month:

  1. Development of Medical Device Registration and Inspection Regulations in Kazakhstan

Last month, several updates regarding registration expertise and inspection requirements in Kazakhstan were enforced:

On 15 May 2019, a new edition of the Order of the Minister of Health of the Republic of Kazakhstan No. 736 ‘on approval of the rules for examination of medicinal products and medical devices’ (Link in Russian) came into effect.

Earlier, on 7 May 2019, the Kazak Ministry of Health enforced another amendment to the Order No. 743 ‘on approval of the rules for assessing production conditions and the quality assurance system for the state registration of medicinal products, medical products and medical equipment’, which came into force (Link in Russian) and updated the criteria for when an inspection is required for the registration of medical devices and pharmaceutical.

Thus, the Kazak regulator clarified that according to amended regulations, the criteria for the inspection of the registration of medical devices in Kazakhstan is required for registering sterile 2A, 2B and 3 class devices in case a manufacturer has never registered or supplied products in Kazakhstan before.

  1. Update on Eurasian Medical Device Regulations

On 21 May 2019, the Eurasian Economic Commission published Recommendation No. 14 (link in Russian) on ‘the methodological recommendations for the expertise of safety, quality and efficiency of medical products for the purpose of their registration within the Eurasian Economic Union’. This is the third-level document intended to ensure the unification of the requirements for the content of evidence materials submitted for registration expertise across Eurasian member states.

Also, potential prolongation of the transition period until 2026 was announced by the Eurasian commission during the annual regulatory conference FarMedObrashenie in Moscow as one of the possible measures. However, up until today, no official regulations/drafts on this matter have been published (to be recalled that for today, the end of the transition period is set as the end of 2021).

In the same conference, the representative from the Eurasian commission confirmed that four registration files for medical devices are currently under review by the Eurasian competent authorities.

  1. Voluntary Experiment on the Identification Measures for Wheelchairs in Russia

The initiative for additional marking for identifying medical devices has been discussed since the beginning of 2019 and is one of the priorities for  the Russian healthcare regulator as a measure of ensuring traceability and counteract the turnover of counterfeit products on the market.

One of the first steps of this initiative was published by the Russian Ministry of Industry and Trade at the end of April 2019 as the draft resolution of the Government of the Russian Federation “on conducting an experiment on labelling with means of identification and monitoring the circulation of certain types of technical means of rehabilitation (wheelchairs classified as medical devices)” – link to the document in Russian.

According to the published document, an experiment on marking with additional means of the identification of certain types of wheelchairs  will be launched in Russia from 1 June 2019 to 1 June 2021.

Participation in the experiment is to be on a voluntary basis, but it is assumed that the pilot project will determine the feasibility of introducing mandatory and additional identification labelling in the future.

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

Dear colleagues,

This is my usual selection of highlights on the changes made to the medical device regulations and trends across Russia and the Eurasian Union over the last month:

 

  1. Some updates on the Eurasian Medical Device Regulations

On 19 April 2019, the Eurasian Commission published Regulation No. 62 ‘On the classification of the areas of intended use for medical devices’ (link in Russian). This third-level regulation document provides a classification system for the intended use of the medical devices that should be used by the applicant in the preparation of documents for the registration dossier.

Earlier, on 3 April 2019, the Eurasian Economic Commission (EEC) published a draft decision ‘On the rules for assessing and authorizing inspecting organizations to conduct QMS inspections.’ (Link in Russian)

According to the official comment in the published document, the EEC does not support the approach proposed earlier, whereby only government bodies can act as inspecting organisations. The proposed draft document contains the requirements and criteria for the QMS inspection organisations, a description of its accreditation procedure (45 days), as well as the subsequent scheduled and unscheduled government audits (at least once over a two-year period).

It should be recalled that on 16 March 2019, it was the end of the transition period which provided manufacturers with a delay in conducting QMS inspections for Eurasian registration.

 

 

  1. The Russian regulator announced a decrease in the number of registration refusals in 2018

On 26 April 2019, the Russian healthcare regulator, Roszdravnadzor, published a video with its annual report for the year 2018. It cites a 38% decrease in the number of registration rejections during last year when compared to the year 2017: 1342 new medical devices were approved and 398 registration applications were rejected in 2018.

rzn-registrations-2018.png

 

Screenshot from the Roszdravnadzor  annual report 2018 shows 38% decrease in number of medical device registration refusals compared to previous year : http://www.roszdravnadzor.ru/news/16631

 

In addition, the regulator announced its priorities for regulations concerning medical devices in 2019 as being: an introduction of the unified database of patients with implanted medical devices; the development of labelling approaches for medical devices; and the organisation and carrying out of activities to inspect the manufacturers of medical devices according to the Eurasian regulation model.

 

  1. Kazakhstan has amended the requirements for inspections

On 10 April 2019, the government of Kazakhstan published the order No. ДР DSM-26 ‘On Approval of the Rules for Inspection in the Sphere of Circulation of Medicinal Products, and Medical Equipment’ (Link in Russian). The document updates the previously established rules and requirements for conducting inspections of manufacturers of pharmaceutical products and medical devices in accordance with Kazakh legislation.

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Three Things You Should Know about Medical Device Regulations in Russia, March 2019:

Dear fellow colleagues,

 

This is my usual newsletter with a selection of updates regarding the medical device regulation landscape in Russia and the Eurasian Union for the last month.

 

  1. International Medical Device Regulators Forum in Moscow

    IMDRF.jpg

The 15th International Medical Device Regulators Forum (IMDRF) and Open Stakeholders Forum were held from 19–21 March 2019 in Moscow. Here are some of the most important outcomes from the event:

The Russian healthcare regulator Roszdravnadzor reported about preparation at the conclusion of the Forum with regard to final versions of the following documents, which are “in process of implementation as part of the Russian regulation system”:

  • ‘Principles of labelling of medical devices, including medical devices for in vitro diagnostics’;
  • ‘Guidelines for the application of the system of unique identification of medical devices UDI’;
  • ‘Terminology of adverse events: terms, structure, codes; Appendix E, F’;
  • ‘Electronic registration for medical devices (IVD & non IVD)’;

On 20 March 2019 the IMDRF issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents explaining how to build submissions using its table of contents structure.

Moreover, ahead of the Forum on 18th March 2019 the Global Medical Device Nomenclature (GMDN) Agency signed a Memorandum of Cooperation with the Eurasian Economic Commission to enable it to use the GMDN to support the improved identification and regulation within the Eurasian medical device regulatory system.

The next meeting of the IMDRF Leadership Committee is planned for 16–19 September 2019 in Yekaterinburg.

 

  1. Russia is Discussing a Potential New Regulatory Path for the Scientific Application of IVDs

On 27 February 2019, the Russian Ministry of Health published a draft federal law (link in Russian) suggesting a potential new regulatory path for some in vitro diagnostics (IVDs) in Russia.

Thus, according to the document, IVDs that are developed, manufactured and applied in the laboratories or medical organisations engaged in scientific activity, may be allowed for use without registration upon condition that special five-year permits are obtained by the said medical/scientific organisation and the IVD product is included in the special register after the assessment procedure (expertise).

The draft document also describes control measures and algorithms of safety monitoring for such IVDs and the requirements for the medical/scientific laboratories that apply such products.

It should be noted that the registration procedure for all IVDs in Russia was simplified in June 2018; however, even today it still remains quite a long and complex process.

 

  1. New Version of the List of Medical Devices with Reduced VAT

On 15 March 2019, the Russian Ministry of Health published a revised version of the draft amendments to the list of medical devices exempted from VAT (link in Russian).

It should be recalled, that a single list of medical devices with a reduced VAT rate was approved by the Russian government in the Resolution 1042 in September 2015; however, since January 2017, after the entry into force of the new Russian classification system some of the medical devices (for example, some cardiac pacemakers, computer tomography, electrocardiography, and pieces of ultrasound and laser equipment) on the list were changed into categories that in practice do not have tax preferences. The published draft with a new version of the list based on a new classification system contains new codes and is intended to remedy this situation.

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