Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union; January 2020

Dear Colleagues,

Welcome to my monthly review of the most important updates in regulations of medical devices in Russia and the Eurasian countries.

In addition to the significant and long-awaited milestone announcement made in early January 2020 on the first medical device approved under the Eurasian medical device regulations, over the last month, there were further updates in local regulation systems, which are discussed below:

1. Criteria for Unplanned Inspections by Russian Competent Authorities

In continuation development of regulations on medical device control procedures in Russia and following the resolution #1433 (link in Russian) enforced in November 2019, on 17 January 2020, the Russian Ministry of Health published the draft regulation ‘on approval of risk indicators of violation of mandatory requirements used as the basis for unscheduled inspections <…> for circulation of medical devices’ (link to the draft in Russian).

The published document provides ten criteria that may be considered by the regulator to be the reasons for initiating unplanned inspections of manufacturers of medical devices and other organisations involved in medical device turnover. Most of the criteria are centred on situations where the regulator receives information regarding certain issues such as violations of current regulation (i.e. about the circulation of falsified, poor quality, or unregistered medical devices), safety concerns with respect to a medical device discovered in the international databases that was not reported in adherence to the Russian regulation, off-label use of a medical device, and such other violations.
According to the information in the regulation database, the draft is currently open for public discussion until 06 February 2020.

However, let me remind you that according to Resolution #970 on state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs planned and unplanned inspections of medical device manufacturers. The list of organisations for planned inspections in 2020 was published by Roszdravnadzor at the beginning of 2020.

2. New Process for Importation of Samples for Registration in Russia

On 28 January 2020, the Russian Ministry of Health published a draft regulation (link in Russian) on the amendment of the procedure for importing samples of medical devices to Russia for registration and registration renewals. It should be noted that this process is currently regulated by the Order #7N.

According to the published document, samples for registration may be imported into Russia according to the special procedure single-use importation permit by the manufacturer of the product, or its authorised representative, registered in Russia as a legal entity. The number of samples allowed for importation is calculated by employing recommendations from laboratories conducting pre-registration testing. The sample importation permit is granted by the competent authority based on the application within five business days. According to the draft, this regulation is not applicable to software.
The draft is currently open for public discussion until 17 February 2020.

3. Belarus is Discussing Amendments in Price Regulations for Medical Devices

At the beginning of January 2020, the Belorussian Ministry of Antimonopoly Regulation and Trade published a draft order ‘on prices of medicines, medical devices, and its spare parts’. According to the published document, the Belarusian government is implementing the price regulation for certain groups of medical devices and their spare parts, which are included in the special lists approved by the Ministry of Health of Belarus. The document also established the trade margins, from 10 per cent to 40 per cent, depending on manufacturers’ selling prices or estimated prices.

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Thank you for following my blog intended to provide up-to-date information on medical device regulations in the region. Your feedback, questions, and comments regarding my updates are always welcome.

Russia and Kyrgyzstan approved the First Medical Device under the Eurasian Regulations

On 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced first medical device approved under the Eurasian medical device regulations  First registration certificate was issued for 2A class neonatal phototherapy lamp manufactured in Russia.  The registration record has also appeared in the Eurasian database. 

Russian and Eurasian Regulatory Roundup of 2019

Dear Colleagues

Over the last year, in the face of challenges and upheavals affecting global medical device regulations (e.g. the upcoming deadlines for MDR/IVDR and Brexit), the Russian and Eurasian medical device regulatory landscape remained calm and barely raised concerns among the global medical device manufacturers. However, as 2019 comes to a close, allow me to summarise some of the 2019 key regulatory updates of the medical device regulatory sector in this region. 

1. Eurasian Medical Device Regulations Recap of 2019

All second-level and most third-level Eurasian medical device regulations have been published and enforced; most local laboratories have obtained Eurasian accreditation and, in some particular cases, they have already started testing. Eurasian regulators are reviewing first registration files; however, as of now, we can hardly announce with confidence that the mechanism of medical device registrations is operating according to the Eurasian rules.

Last year’s crucial update came about when the proposed changes transitioned from the local regulations of the Eurasian member states to the Eurasian medical device regulations system. The initial deadline of 31 December 2021 was changed by Decision #142, published in September 2019. The document proposed by the Eurasian commission postponed the re-registration deadline until 31 December 2026 for all medical devices approved by the Eurasian member states before 31 December 2021. No changes are expected for the registration of new medical devices: local registration of new products will be allowed only until 31 December 2021 after which all new registration submissions must be made using the harmonised Eurasian procedure only. It should be noted that the Eurasian member states must first ratify Decision #142 before it can come into effect; however, no information is available on such ratification for the end of 2019.

Another significant milestone for the Eurasian medical device regulation over the last year was the end of the transition period of QMS inspections, established in Regulation #106 in March 2019. All middle- and high-risk medical devices henceforward may be approved in the Eurasian Union only after the quality control audit of the manufacturing site by Eurasian regulators; as of now, the list of such inspection bodies remains unclear. In September 2019, the Russian Ministry of Health published a draft policy on determining the QMS inspection fees (link to the document in Russian); the policy elaborates on the inspection’s cost and calculation algorithms (as of now, the document continues to have a draft status).

Several other important third-level Eurasian medical device regulations were adopted and implemented in 2019:

  • Regulation #62: the classification of the usage areas of medical devices (link in Russian) (published on 16 April 2019);
  • Recommendation #14: the examination of the safety, quality and efficacy of medical devices for registration in the Eurasian Economic Union (link in Russian) (published on 21 May 2019);
  • Recommendation #29: procedural recommendations on the content and structure of documents of the medical device application dossier (link in Russian) (published on 8 October 2019).

It is also interesting to mention that over the last year, the Russian and Kazak regulators announced the first approved registrations for pharmaceutical products. These registrations comply with the Eurasian pharmaceutical regulations, which were launched simultaneously with the developing medical device regulations. 

2. Russian Medical Device Regulations Development in 2019

In parallel with the development of the Eurasian system, several important updates on the local Russian medical device legislation over the last year were announced. Although Russian regulators cite a decrease in the number of registration rejections during the last year compared with the previous one, the registration of medical devices in Russia remains a long and complicated process. Nonetheless, the industry’s experience of dealing with the regulatory requirements have made the process more predictable and understandable. 

In August 2019, the Russian regulators solved long-lasting VAT issues of multiple medical devices. The amendments introduced in the rules of medical device assessment clarified the regulatory requirements and approaches for the registration of medical devices containing medicinal products and active pharmaceutical components. In 2019, additional regulations for alcohol-containing medical devices were adopted; these regulations introduced new mandatory application procedures for the special list of such products.

Of all the debated challenges and questions concerning the registration process over the last year, I can mention the unclear requirements for registration trademarks and registration approaches of the Medical Software Regulation.

One of the important initiatives that announced its priorities for Roszdravnadzor over the last year was the development of traceability and identification measures approaches for medical devices. Two initiatives were launched; first, a voluntary trial of rehabilitation equipment and wheelchairs was launched in September 2019. Second, a pilot project was carried out to ensure the traceability of diaper napkins and coronary stents in 2020–2021.

Notably, in March 2019, the Russian Government discussed and approved the concept of ‘Regulatory Guillotine’ as a measure against excessive and ineffective regulations. This initiative allows the overseeing of the existing regulatory frameworks in different areas, such as the regulation of pharmaceuticals and medical devices, and replacing them with new reasonably justified regulatory requirements. This approach will unfold beginning in February 2020. Although very few documents on medical device circulations are currently available, we can expect significant changes related to this initiative in the coming year.

Russia was the chairman of the IMDRF in 2019 and held two meetings in Moscow and Yekaterinburg where it announced the development of Russian medical device regulatory requirements after global harmonisation principles.

3. Updates on Other Countries in the Region

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

 

Dear Colleagues,

There have been no major changes in the regulatory landscape of Russian and Eurasian medical devices for the past month, but  this is my usual newsletter with several short updates which  are good to know if you are interested in medical devices regulation in this region:

1. Updates in Medical Device Control Procedures in Russia

In November several new updates were introduced to strengthen control procedures for medical devices and pharmaceuticals in circulation on the market from Russian healthcare regulators.

On 9 November 2019, the Russian government published Regulation No. 1433 (link in Russian), amending some aspects of the procedure for the inspection of medical devices manufacturers and distributors. According to the published document, within three months, the Ministry of Health is developing a risk indicators  i.e. parameters deviations from which might indicate a likelihood of violations of mandatory requirements for the circulation of medical devices, which are intended to be used for unscheduled inspections.

Under Regulation No. 1459 published on 15 November 2019 (link in Russian), Russian healthcare regulator Roszdravnadzor is empowered to conduct test purchases of medical devices and medicines to verify compliance with regulations, i.e. to check on the sale of falsified, poor-quality and non-registered products.

It should be noted that according to the current regulation, inspections of the medical device manufacturers and distributors are carried out in accordance with the annual plan published by Roszdravnadzor. In limited cases, unplanned inspections may be conducted. Strengthening control of the medical devices on the market is a trend that has been evident in Russia over the last several years.

2. Development of Medical Software Regulation in Russia
In November 2019, the Russian Ministry of Health announced the start of work on the implementation of changes to the classification of the software as a medical device. According to the regulator, improvements should be made following the IMDRF guidelines.

As of today, the medical software is within scope of the Russian definition of a medical device, and some years ago Roszdravnadzor clarified the requirement for its mandatory registration, but to date, no specific guidelines are available in the Russian regulations on medical devices.

3. Simplified Approval Path for Refurbished Medical Devices in Belarus

On 16 November the Belarusian Ministry of Health clarified procedures for obtaining import permits for Belarus in the re-used and refurbished medical devices received as foreign donations. The published letter ( link in Russian) sets out a simplified approval process for refurbished medical devices and rehabilitation equipment of I-Class, on the condition that their residual life is not less than one year.

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

 

Dear Colleagues,

Welcome to my monthly review of medical device regulatory changes in the Eurasian region:

  1. Eurasian Guidance on the Content and Structure of the Eurasian Medical Device Registration Dossier 

On 8 October 2019, the Eurasian Commission published Recommendation #29 ‘On methodical recommendations on the content and structure of documents of the registration dossier for a medical device’(link in Russian). This published document describes the requirements regarding the format, as well as language and legalisation, of documents covering 30 sections of the Eurasian registration dossier of a medical device depending on risk class. Annex II of the document provides guidance on the format of clinical data depending on the safety class of the device and date of clinical trials. Also included is the criteria for acceptance of clinical data from clinical centres outside of the Eurasian Union and requirements for clinical data for an analogue/equivalent device.

It should be noted that requirements for the registration file were previously published and can be found in Annex IV of Regulation #46 (link in Russian), and requirements for the content of technical files is in Annex II and Annex III of Regulation #29 (link in Russian).

  1. New Devices Added to the List of Regulated Implantable Devices in Russia

On 8 October 2019, the Russian government released Resolution #2333-R (link in Russian), which extended the list of medical devices which can be implanted into the human body for providing medical care under the programme of State Guarantees of Free Provision. According to the published document, there are four new types of devices including polymer ligation clips, ligation end loops, implantable dual chamber MRI compatible pacemakers and associated leads.

The prices for medical devices in the list for these programmes are regulated in the manner prescribed by Resolution #1517 released in 2015. 

For today, information about registered prices for these implantables is available on the official website of Russian healthcare regulator Roszdravnadzor 

  1. Kazakhstan Updated Medical Device Classification Guideline. 

On 2 October 2019, the Ministry of Health of Kazakhstan released Order #KR-DCM-129 (Link in Russian) and updated the rules for the classification of medical devices and in-vitro diagnostics in Kazakhstan. This document also contains rules for medical software classification. There are still four classes of medical devices categorised by invasiveness, duration of use, contact with patient, implementation with vital organs, and use of energy sources. Compared to previous revision, the structure of this new version of the Kazak classification is closer to the Eurasian medical classification; however, the two are not totally identical and still contain different classification algorithms. 

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It should also be mentioned that, in October 2019, some minor changes in tax regulations for medical devices have been enforced in Russia and several national GOST standards for plasters, surgical/operating room drapes, dental filling materials and hit implants have been updated and published.

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Your feedback, questions and comments regarding my updates are always welcome🙂

Three Things You Should Know About Medical Device Regulations in the Eurasian Union, September 2019

 

 Dear colleagues:

This is my monthly selection of updates on medical device regulations in the Eurasian region:

  1. Changes to the Eurasian Transition Period for Medical Devices

Here is the long-awaited update on the Eurasian transition period for medical devices. On 5 September 2019, the Eurasian Economic Commission published Decision no. 142 (link in Russian) which contained an approved draft of the proposed changes to a transition period for registration for medical devices. According to this document, if a medical device is approved in a Eurasian member state before 31 December 2021, it may be re-registered <only in this member state> using the local re-registration procedure until 31 December 2026. Such a device can be on sale in this member state <but not the whole Eurasian Union> until the expiry of the registration certificate.

Previously, the Eurasian Agreement on medical devices required re-registration of all medical devices using the Eurasian registration procedure before 31 December 2021. In the last two years, several proposals from Eurasian member states to change these transition deadlines have been discussed.

Registrations of new medical devices before 31 December 2021, can be submitted using either the local registration procedure or the Eurasian registration procedure. After 31 December 2021, all new medical devices should be submitted for registration using the harmonised Eurasian procedure only.

The Eurasian member states must first ratify (within 90 days) the draft of Decision no. 142 (link in Russian) before this comes into effect.

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While the Ministry of Health of Kazakhstan recently reported the first Eurasian approval of a pharmaceutical product,  activity on Eurasian medical device registration is still not too fast: for today there is still minimal information about products submitted for registration. Twenty-five laboratories are accredited to perform registration type testing. However, there is still no clarity as to when the quality management system (QMS) inspection, which is required for registration may begin.

  1. Draft Guidance to Determine the Costs of QMS Inspection in the Eurasian Union

On 2 September 2019, the Russian Ministry of Health published a draft policy for determining the fees for a QMS inspection before registration of the medical device can take place within the Eurasian Union (link to the document in Russian).

According to Regulation no. 106, which came into force in March 2018, the QMS inspection of manufacturing sites is mandatory for the registration of most IIA-III class medical devices in the Eurasian Union. The scope of the QMS inspection includes the assessment of quality sub-systems, i.e. design and development, document and record management, production and output control, corrective and preventive actions, and consumer-related processes.

The document proposes rules for calculating the cost of an inspection which depends on the number of employees of the enterprise and its location. The document also suggests the duration of the inspection is from four to eleven working days, and that the maximum cost is limited to 2,600,000 RUB (approx. 40,000 USD), excluding the cost of translation services.

  1. New Rules for Technical Testing of Medical Devices in Kazakhstan

On 6 September 2019, the Ministry of Health of Kazakhstan released Regulation KR DSM-124 (link in Russian) regarding technical trials for medical devices as part of the national registration procedure. According to the document, technical tests of medical devices (not required for in-vitro diagnostics) are carried out as type testing of samples or as data analysis (e.g. for some large-sized medical devices). These tests include assessment of the parameters provided in the technical or operational documentation, evaluation of the ‘design and operability of a medical device in terms of safety, ease of use, operational and ergonomic characteristics’, and an assessment of the labelling and packaging of a medical device. The duration of technical testing, according to the rules, should not exceed 30 calendar days.

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I would like to thank LIMI Consulting who helped me prepare the update regarding the Kazakhstan regulation in this post.

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