Three Things You Should Know About Medical Device Regulations in Russia – August 2019

Dear Colleagues,

August was rather quiet in Russia and the Eurasian countries in terms of new medical device regulations released. Nevertheless, for those of you interested in the field, here is the usual selection of my monthly highlights:

 

  1. Extension of the List of Medical Devices with 0% VAT in Russia

On 19 August 2019 the Russian government published resolution no. 1054 (Link in Russian) and extended the list of medical devices which are not subject to VAT.
It should be recalled that the list was launched in 2015; however, since January 2017, when a new OKPD2 (ОКПД-2) classification came into force in Russia, a significant number of new codes for medical devices, such as certain surgical instruments, computer tomography, certain diagnostic devices, X-ray and ultrasound machines, and electro-diagnostic and scintigraphic devices, were missing from the list. As implemented by Russian tax regulations, the VAT for these products was changed from 0% to 18%. This has led to difficulties with their importation and tax/customs clearance for their distributors and manufacturers.
The updated list uses a new classification system and includes more than 90 new (OKPD-2) codes for medical devices previously missing codes. It also provides VAT preferences for ‘old’ (OKP) codes for medical devices registered before 2017.

 

  1. IMDRF Meeting in Yekaterinburg

In 2019 Russia is the official chair of the International Medical Device Regulators Forum (IMDRF). The sixteenth IMDRF meeting and Open Stakeholders Forum will be held from 16-19 September 2019 in Yekaterinburg. The meeting’s key topic has been announced as artificial intelligence in healthcare and the meeting will address regulatory and standardisation activities for medical devices based on artificial intelligence. A detailed agenda is published on the official webpage of the event. Registration is open until 9 September 2019.
It should also be noted that the Russian healthcare regulator Roszdravnadzor announced an internal IVD working group meeting taking place from 20-22 August 2019 within the framework of the IMDRF forum.
The previous IMDRF meeting took place in Moscow in March 2019.

  1. Update on Notification Requirements on the Start of Activities in the Medical Device Domain

On 9 August 2019 the Russian Ministry of Health enforced Order 3239 (link in Russian) with a new edition of the regulation on notifications on the start of activities in the field of circulation of medical devices. According to the enforced document, any legal entity involved in medical device circulation in Russia must notify healthcare regulators prior to the start of activities. The requirement is not new, but a new edition of the regulations harmonised it with other regulations and allows for the submitting of notifications to any territorial body of Roszdravnadzor in Russia.

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

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, 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.

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, May 2018

Dear Colleagues, 

Here is my usual monthly selection of highlights about what happened in the Russian medical device regulations landscape in May 2018:

  1. Simplification Requirements for Substance-based Medical Devices (draft)On 30 May 2018, the Russian Ministry of Health published a draft regulation suggesting the simplification of requirements for registration and pre-registration testing of substance-based medical devices in Russia.
    According to regulation #11N, enforced in March 2017, one of the requirements for registration of medical devices with ancillary pharmaceutical substances is mandatory registration of the pharmaceutical component of the product in the Russian register of medicinal products prior to registration of the device. This became one of the most pressing regulatory problems in Russia and increased the number of registration rejections in 2017.
    The amendments proposed in the published draft suggest replacing the requirement above with submitting ‘…documents on quality of pharmaceutical substance <…> taking into account the intended use of a medical device <…> and issued according to the regulation of the country of origin of this pharmaceutical component’. The published draft is now passing through the procedure of public discussions by the end of June 2018.
  1. Mandatory Multi-Central Clinical Trials for IIB and III class devices (draft) 

    Another suggestion of the published draft regulation is the expansion of the list of cases when clinical trials involving human subjects are required for medical device approval in Russia.
    Currently, according to resolution 2N, registration of most medical devices in Russia is mainly based on evaluation of clinical data, and clinical trials involving human subjects must be conducted in accredited clinics after the approval of the ethics council in a limited number of cases: for new types of medical device; for new complex or unique or special methods of prevention, diagnosis or treatment; and in cases where the effectiveness or safety of the medical device are not confirmed in the evaluation of clinical data.
    The published draft document tightens these rules and introduces a requirement for all medical devices of IIB and III classes to undergo mandatory clinical trials involving human subjects, to be conducted in at least two medical organisations under a single clinical trials protocol.
    The same draft document also suggests the innovative new possibility of conducting on-site clinical trials in limited cases.
    It should be also noted that the amendments suggested in the draft document would make Russian and Eurasian clinical trial requirements more similar. Proposed amendments are now passing through the procedure of public discussions by the end of June 2018.

  2. Clarification on application of a reduced tax rate for medical devices in RussiaAt the end of May 2018, the Ministry of Finance of Russia published a letter On the application of the VAT rate of 10 per cent for imported and sold medical products in Russia (link in Russian). In this letter, the regulator clarifies that the list of medical devices taxed at a rate of 10% is approved by Decree of the Government of the Russian Federation N 688 (link in Russian to the latest version, updated on January 23, 2018). This should be guided by the codes of medical products, determined in accordance with the nomenclature of Eurasian customs commodity code EAEU TNVED and Russian product classification code OKPD 2.

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

Dear colleagues,

Welcome to my monthly update!

One may note that February 2018 was a fairly quiet month in the regulatory landscape for medical devices in Russia. However there are several recent minor updates which may be of interest:

  1. Updated List of Medical Products Taxed at 10% VAT

At the end of January 2018, the Russian government updated resolution # 688 with a list of medical products taxed at the reduced rate of value added tax (VAT) of 10% (link of updated resolution in Russian). An updated consolidated version of the list was aligned with the new national classification of products (enforced since January 2017).

In this context it should be recalled that Russian legislation grants VAT preferences (0% or 10% VAT instead of 18% as a ‘general rule’) for importing and selling most types of medical devices. The list of medical devices taxed at 0% was last updated in November 2017.

 

  1. List of Alcohol-Containing Medical Devices

At the end of January 2018, the draft regulation, ‘on formation of the list of alcohol-containing medical products’ (link in Russian), was published. According to the document, medical devices ‘in a liquid form of release containing the pharmaceutical substance of ethyl alcohol’ should be included in the special list by special commission of the Ministry of Health depending on a number of criteria (volume of consumer packaging, cost and functional purpose of a medical device). The commission is expected to revise the list no more than once a year and no later than 31st March. It is also expected that medical products included in the list will not be regulated by the Russian Law on State Regulation of Production and Turnover of Ethyl Alcohol and Alcohol-Containing Products, which was amended in January 2018.

 

  1. Weighted Average Prices for Polyvinylchloride Plastics Consumables

On 1st February 2018, the Russian Ministry of Health of the Russian Federation published a letter (link in Russian) proposing the updated weighted average prices for foreign disposable medical devices made of polyvinyl chloride plastics (PVC).

The weighted average prices are used for calculation of the guaranteed maximum price for state and municipal purchases according to the methodology provided in Order № 759N (link in Russian) by the Ministry of Health and the Ministry of Industry and Trade in October 2017.

A new scheme for the public procurement of consumable medical devices made from PVC was introduced in Russia in August 2017 with significant extension of the previously adopted Resolution No. 102 ‘On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products to Procurement for State and Municipal Needs’.

 

Thank you for following my updates!
Just to remind you that you may also follow Russian and Eurasian medical device regulatory updates on myTwitter @MedDevRus

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

Dear Colleagues and Group Members,

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

 

  1. Development of Eurasian Medical Device Regulations

 

On 4 September 2017, the Eurasian Economic Commission published Recommendation No. 17, (link in Russian) ‘On the list of voluntary national standards that […] ensure conformity of a medical device with the Eurasian Essential Requirements for the Safety and Efficiency of Medical Devices’. The document harmonises existing national standards (155 voluntary standards for different types of medical devices and 43 standards for in-vitro devices) of the member states of the Eurasian Union and correlates them with the relevant requirements of the Essential Checklist.

In addition, earlier in September a number of drafts concerning medical device classifiers were published by the Eurasian Commission:

  • classifier of changes in the registration dossier of a medical device (link in Russian)
  • classifier of documents in the registration dossier of a medical device (link in Russian)
  • classifier of medical device area of usage (link in Russian).
    Usage of codes of the above classifiers are expected to be mandatory across several steps of medical device turnover in the Eurasian Union

At the same time, Roszdravnadzor (the Russian medical device regulator) created on its website the section ‘Registration of medical devices within the framework of the Eurasian Economic Union’, in which all Eurasian medical device regulations that came into force at that time were summarised.

Despite all published regulations, as of the end of September 2017, applications on Eurasian medical device registration process are still not working.

 

  1. Russian Ministry of Finance Clarified Rules for Medical Device Tax Exemptions

On 11 September 2017, the Ministry of Finance of the Russian Federation published a letter # СД-4-3/1794 (link in Russian) in which it recalled the rules for exemption from value added tax (VAT) when selling medical devices in Russia.

The regulator also confirmed the same VAT exemption for both ‘new’ and ‘old’ registration documents for the period 1 January 2017 to 30 June 2017 (i.e. the period before the amendment of the Russian tax code).

In this context it should be recalled that in February 2017, the Russian government published Resolution #160 (link in Russian) and extended to 1 January 2021 the deadline for the administrative replacement of the ‘old’ Russian medical device registration certificates.

 

  1. Medical Devices Incorporating a Medicinal Substance – Difficulties in Registration in Russia*

The registration of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances is now one of the most pressing regulatory problems in Russia.

Resolution (Order) #11 N of the Russian Ministry of Health (link in Russian), which came into force in March 2017, requires the mandatory registration of all such chemical or pharmaceutical components as pharmaceutical substances in the Russian Federation.

On 25 September 2017, 38 manufacturers and distributors of medical devices in Russia submitted a collective letter to Russian medical device regulator Roszdravnadzor, the Ministry of Health, and the Ministry of Industry and Trade, in which they drew attention to serious difficulties with, and in some cases the impossibility of, state registration of whole groups of medical devices (for example, dental cements and adhesives, drug-eluting stents, cosmetic fillers…) under new requirements.

The petition contains an analysis of the current regulations of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances, as well as a request to regulators to clarify their position on this issue and correct contradictions in legislation. The issue has received wide coverage in the Russian media.

 

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* I would like to express my thanks to Medrelic – a Russian consulting company for the registration and certification of medical devices – for kindly providing material and sharing expertise on issues regarding the registration of medical devices incorporating pharmaceutical substances.