Response to COVID-19 in Russian and Eurasian Medical Device Regulations

Dear Colleagues,

This is my monthly update regarding changes to medical device regulations in Russia and the Eurasian Union; this month will be entirely devoted to a review of recent legislation changes related to the coronavirus COVID-19 outbreak:

  • On 26 March 2020, the Russian Ministry of Health announced a green channel regime for approval in Russia for medical devices intended for the diagnosis of coronavirus COVID-19 infection. The published letter on this matter (link in Russian) informs that ‘in condition on rules of submission of documents for registration are respected, medical devices intended for diagnosis of coronavirus infection will be performed in shortest time’. The same document also announced that pre-registration consultations with manufacturers regarding the approval of medical devices that are intended for the diagnosis of coronavirus COVID-19 infection are provided by expert institutions at no cost.
    However, it should be noted that this announcement does not introduce any new approval track/route, but rather expedites the existing testing and registration procedure.The first coronavirus IVD assay was approved in Russia, according to the information from the national medical device register, on 11 February 2020.
    For 30th March 2020, according to the Russian Minister of health, there are seven assays approved in Russia, and review of such applications <by the regulator> is performed “within one-two days”.
  • On 18 March 2020, the Russian government released the Resolution #299 (link in Russian) and simplified the registration route for 36 types of low-class, protective medical devices, including surgical/protective face masks, respirators, medical protective clothes, surgical suits, medical gloves, overshoes, and others.
    According to the published resolution, Roszdravnadzor, the Russian medical device regulator, will make a decision on the approval of such protective devices within five days from the receipt of the registration file; this will be carried out on the condition that a manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trials reports) within five months from the approval from the regulator. In the case where discrepancies (between data submitted for registration and in the test reports) appear, such approval may be withdrawn. The above mentioned resolution was followed by methodical guidelines (link in Russian), clarifying a new, simplified procedure.
  • On 2 March 2020, the Russian government released the resolution #233 (link in Russian) and implemented a temporary ban on the exportation of certain types of medical devices and protective equipment from Russia, including face/surgical masks, respirators, protective glasses, medical protective clothes, and others – 16 types of medical products are included in the restriction list. According to this resolution, the export ban on these devices will be effective until 1 June 2020.
  • On 25 March 2020, the Eurasian Commission published the decision #25 (link in Russian) and annulled the importation customs fees for several medical devices intended for the diagnosis and prevention of COVID-19 infection, which are included in the special list provided in the same document – the list includes IVD assays, protective clothes, and personal protective medical products. The document grants exemption from fees on the importation of products on the list from 16 March until 30 September 2020, in the territory of the Eurasian Union.
  • Since 26 March 2020, the Russian parliament has been discussing the draft federal law (link in Russian), which may grant the Russian government the right to introduce a special procedure for the approval of medical devices, as well as the suspension of the wholesale and retail sale of medical devices in Russia for up to 90 days in the case of an emergency or epidemic.
  • All registration inspections for medical device manufacturers have been cancelled/postponed by the Ministry of Health of Belarus (link of the published letter in Russian), as well as the Kazak competent authority (link to the announcement in Russian).

The first cases of COVID-19 infection were reported in Russia on 31 January 2020, and until today the rate of infection continues to climb. On 30 March 2020, Russia closed its borders and imposed a nine-day national shutdown.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in February 2020

 

Dear colleagues,

I am pleased to deliver my usual end-of-the-month update on the highlights of medical device regulations in Russia and the Eurasian Union.

  1. Updated Criteria for Software as Medical Devices in Russia

On the 14th of February 2020, the Russian medical device regulator Roszdravnadzor published a letter that clarifies the criteria by which software may be considered a medical device (and require registration) and annulled previous requirements that had been applied to software since December 2015.

According to the letter, the Russian medical device regulator considers software to be a medical device when it meets all of the following criteria:

  • It is a computer program or its module (regardless of the program’s hardware platform and/or mode of distribution);
  • It is intended by the manufacturer to be used for medical care;
  • It is not a component of another medical device; and
  • It is intended to interpret sets of data received from medical devices, or entered by medical professionals, with the intention that the interpretations will be used for medical purposes.

According to several examples provided in the published document, medical software is not considered a medical device if it is intended for:

  • Hospital administration
  • Health and lifestyle management
  • The archiving and administration of medical data and medical images without the intention of interpreting them
  • The control and technical maintenance of medical equipment
  • Communication between doctors and patients
  • Educational and informational use
  • Receiving data from medical devices but not for medical care.

It should also be noted that, earlier in January 2020, the Roszdravnadzor announced plans to simplify the approval process for some IT healthcare products in Russia and to create a dedicated working group to discuss the registration of medical software.

  1. Draft on the Amendment to the Eurasian Medical Device Registration Procedure

On the 18th of February, the Eurasian commission published a draft document on an amendment to the rules of registration and examination of medical devices in the Eurasian Union (link in Russian). The current version of these rules (Regulation 46) is available in English.

The published draft suggests several clarifications and amendments to the definitions used in the regulations, as well as a clarification of the procedure by which member states accept registrations. It also suggests a protocol for making, and providing notification of, amendments to the registration dossiers of devices, and a clarification of the procedure for cancelling registration certificates.

The document is open for public discussion until the 20th of April 2020.

  1. Update on the Regulation of Medical Devices with Ethyl Alcohol

On the 9th of February 2020, the Russian healthcare regulator Roszdravnadzor enforced regulation 7975 ‘On approval of the regulation on the commission for the formation of a list of alcohol-containing medical devices, the production of which is not covered by the Federal law on the regulation of ethyl alcohol’ (Link in Russian).

Roszdravnadzor published a reminder to the industry that the process of forming this list is carried out on the basis of applications from manufacturers, or their authorized representatives, that are submitted to Roszdravnadzor between the 1st of January and the 30th of June.

It should be noted that the rules for the formation of the aforementioned list were enforced previously in July of 2019. Medical products included in this list are excluded from general alcohol regulations, such as Federal law 171, in Russia. According to this law, ‘alcohol-containing medical devices’ are medical devices in liquid form containing the pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol.

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Some other minor updates over the last month merit mention: Clarification letters have been published by the Russian Ministry of Finance regarding the application of a reduced tax rate for some medical devices (link in Russian). The tax rate for medical devices that will be applied after 2022 (link in Russian) and for custom-made medical devices (link in Russian). Several administrative regulations regarding the control of medical devices have also been cancelled (link in Russian) and replaced by new editions (link in Russian).

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🙂