Russian and Eurasian Medical Device Approval Routes and Regulatory Updates for 2023

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Here is my traditional end-of-year review of the key updates in Russian and Eurasian medical device regulation over the last year and expected changes in the nearest future, as well as short overview of medical devices approval routes which are currently valid in Russia.

Regular registration procedure

The national registration procedure according to the regulation #1416 is remaining the principal and most common approval route for major part of new medical devices coming into the Russian market.

On 13 February 2023, the national medical device registration procedure has been officially prolonged, while full transition into the Eurasian medical device regulation model, that was previously planned for 31 December 2022, has been postponed until 31 December 2025. That means that until this deadline, medical device registration submissions in Russia may be prepared according either to the national or to  Eurasian medical device registration rules.

  • Another important change expected in 2024 is entry into force of the new national registration procedure according to the draft that was published and updated since April 2023.

    The new revision of the registration rules contains multiple updates, and overall make national registration process more harmonized with Eurasian medical device registration requirements.

    Among other proposed changes, the draft regulation is introducing separate registration procedure for domestic medical devices and simplified registration for certain group of low class medical devices, in-vitro diagnostics and IT-products including artificial intelligence. According to the draft document, the new procedure will allow electronic application and provide additional materials using electronic submissions.

  • It should be also mentioned, that on 1 September 2023, the Russian Ministry of Health introduced updated procedure of importation of samples of medical devices for national registration.

    Simplified pathways

In parallel with abovementioned “regular” registration process, for the end of 2023, there are also several simplified pathways to approval for medical devices and in-vitro diagnostics:

  • “Fast track” national route for approvals according to the regulation #552 for medical devices in risk of shortage. This procedure was introduced on April 2022 as a response to restrictive economic measures against the Russian Federation and implies simplified administrative requirements and expedited timelines for review for temporary registration (until 1 January 2025) for the medical devices listed in the regulation. The last revision of this list was published by Russian medical device regulator Rosazdravnadzor in August 2023 and contains more than 1900 types of medical devices.  

At February 2023, the regulator says about 31 medical devices approved under this procedure in 2022. 

  • Over the last year, there were no significant updates for another simplified registration route according to the regulation 299 which is applicable since March 2020 for 36 types of class I medical devices and protective equipment. The official timeline for registration review for these products are significantly shorter (up to five business days) on the condition that the manufacturer provides reports on type-testing and clinical assessment performed in Russia within five months after the approval date. It is worth mentioning, that in case such reports are not provided within established timelines, the regulator may withdraw such type of registration.
  • There were no major updates in the procedure of temporary registrations of particular batches of certain medical devices and in-vitro diagnostics intended for use in conditions of military and emergency situations according to the regulation #430 that was enforced in April 2020 as response to COVID-19 pandemic and afterward prolonged until 1 January 2025. Roszdravnavnadzor says about 158 medical devices registered over 2022.
  • At April 2023, the Russian medical device regulator announced first approval according to the new route intended for certain in-vitro diagnostics. This procedure according to the regulation #2026 is effective since November 2021 and applicable for certain in-vitro diagnostics intended for use within the same organization where it was manufactured.

Eurasian Medical Device Registration

As mentioned before, the full transition from national into Eurasian medical device regulation model that was discussing since 2016 and previously planned for 31 December 2022, has been postponed until 31 December 2025.  For the end of December 2023, there are 35 medical devices approved according to the Eurasian procedure,  most of these medical devices manufactured within Eurasian countries. Over the last year, Eurasian economic commission continue to update existing Eurasian medical device regulations and released the following documents:

Russian and Eurasian Medical Device Regulations – Highlights 2022

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  1. Russian national medical device regulatory system

    Over the several years, a deadline for the end of the Russian national procedure of the registration was set as 1 January 2022. However, a few days before 2022, the Eurasian commission came up with a protocol for postpone the national registration deadline for another year, until 1 January 2023.

    Due to the length of procedures of ratification and signing the protocol by all Eurasian Member states, the national registration procedure was closed during 6 months, and re-opened only in June 2022, when this prolongation came into force.

    In August 2022, the Council of the Eurasian Commission announced approval of further prolongation of the Eurasian transition period with possibility of medical device registration submissions according to the national regulations until 31 December 2025.

    This draft protocol has been circulated to the Member States and will come into force after ratification and signing.  In November 2022, proposal on new prolongation was approved by the Russian government, but for end of December it is not yet been enforced officially.
  • Updates in the registration procedure:

    Over the year 2022, we me may see several updates in the national registration procedure:

    -Since March 2022, a new regulations for pre-clinical and clinical testing for medical devices (link in Russian) have been enforced;

    -Since August 2022, Russian medical device regulator Roszdravnadzor simplified the process of importation of samples for testing and registration (link in Russian);

    -In September 2022, the Russian Ministry of health introduced a requirement of quality management system inspections for national registrations and renewal (re-registration) procedures of sterile IIa, all IIb and III class medical devices (link in Russian). This requirement was established with a transition period until 1 June 2023, until this date QMS inspection may be postponed for the next two years after registration approval. Since November 2022, the Russian Ministry of health is discussing extension of this deadline until 31 December 2023.

  • Updates in post-market requirements:

    It is worth mentioning two quite significant updates in the Russian post-market medical device regulation over the last year:

    Since February 2022, according to the regulation #1113 (link in Russian), Manufacturers or their Russian authorized representatives are required to submit annual clinical post-market monitoring reports for class III medical devices and IIB implantable devices registered in Russia after January 2021;

    Since March 2022, according to the regulation  #11020 (link in Russian) for the purpose of safety monitoring of medical devices on the market, Manufacturers and Distributors have to inform Roszdravnadzor within 15 days, about every unit of any medical device imported into Russia;

  • Other significant updates in the national medical device regulations:

    Since September 2022, the Russian government released the regulation #2425 (link in Russian) and updated a lists of products subject to mandatory GOST certification and declaration. Current GOST certificates and declarations of conformity for products on the market, mentioned in the previous versions of the lists, will remain valid until 1 September 2025.

    Medical and in-vitro devices intended for diagnostics and treatment of COVID-19 infection are still may be registered in Russia via simplified registration process until and receive approval until 1 January 2025.  In the same time, part of these products already registered before, have been withdrawn from the market by the regulator.



    2.Expedited registration process for medical devices in risk of shortage and other measures related to geopolitical situation

Since April 2022, the Russian government released several regulations “intended to improve the stability of the market for socially important goods and mitigate a risk of inventory shortage for medical devices caused by the economic restrictive measures imposed against Russia”.

The measures, among others, include “fast-track” medical device approval process for certain groups of medical devices and simplified re-registration procedure in case of change of the raw material and components for domestic medical device manufacturers;

The resolution #552 (link in Russian) enforced on 1 April 2022, introduced a possibility of the “fast track” registration for medical devices included the special list. Since April 2022, the list of devices, that has determined to be in shortage at this time, has been extended several times, and for the end of the year, it contains more than 1800 codes. Depending on classification of the device, (formal) timeline for fast-track review by the Regulator may start from five-business days while certain administrative and testing requirements for such submission are simplified. The registration approval for this procedure is granted for the limited period (initially established until 1 September 2023 and later prolonged until 1 January 2025). For the end of 2022, 18 medical devices have been approved according to this simplified process.

Among other measures, as a response to economic restrictive measures and complexity of the logistic process,  the Russian regulators introduced ban for export from Russia of certain medical devices included in the special list, legalized a “parallel importing” in Russia for certain goods including medical devices without the permission of the trademark holder, introduced a requirement for manufacturers and importers of medical devices to notify the regulator prior to suspend or terminate business activity in Russia.

3. Updates in the Eurasian medical device regulatory system

Overall, we did not observe a major breakthrough in the development of the Eurasian medical device regulatory system over the last year.

For the end of the year 2022, there are 14 medical devices registered according to the Eurasian medical device registration system (versus 7 approvals in the beginning of the year), most of registered medical devices are manufactured by domestic Eurasian companies;

There are 22 testing laboratories and 41 medical organizations accredited for conducting testing and clinical trials of medical devices according to Eurasian requirements;

In July 2022, the Eurasian Commission released the Regulation # 144 (link in Russian) implementing new edition of Eurasian medical device registration rules with several updates in the procedure;

In August 2022, the Council of the Eurasian Commission announced approval of further extension, until 31 December 2025, of the Eurasian transition period medical devices registration submissions open both according to national and Eurasian regulations;

In December 2022, the Eurasian Commission announced approval of the roadmap for the further transition the common market of medical devices, which, according to the Commission, will ensure “unconditional transition” for registration of medical devices after end of transition period.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, August 2022

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1.Draft Protocol on Prolongation of the Eurasian Transition Period until 2025

On 19 August 2022, the Council of the Eurasian Commission announced (link in Russian) approval of the protocol of amendments to the Eurasian Agreement on common principles and rules of circulation of medical devices and prolongation until 31 December 2025 of the transition period with possibility of registration of medical devices according to the national regulations.
According to the announcement on the website the Eurasian commission, the draft protocol with abovementioned amendments was forwarded to the Eurasian member states for carrying out procedures necessary for signing and implementation of this regulation.
The Eurasian Agreement on common principles and rules of circulation of medical devices was enforced by the Eurasian Commission in 2016; the transition period, that was initially established as 31 December 2021, was already extended for one year in June 2022.

2.Simplification of the Procedure of Importation of Samples of Medical Devices for Registration

On 8 August 2022, the Russian medical device regulator Roszdravnadzor has announced (link in Russian) change of the procedure of importation of samples of medical devices for registration in Russia. 
Since that date the requirement to obtain the sample importation permit for registration was cancelled and replaced by new requirement to submit online notification with information on imported samples. 

3.Enforcement of the Requirement on QMS Inspections for National Registration Procedure

On 1 September 2022, the regulation #135 (link in Russian) is coming into force. This document is establishing rules for the inspection of quality management systems (QMS) for medical device manufacturers and introduces mandatory requirements to perform QMS inspection and submit QMS inspection reports for national Russian registration and amendment procedures for IIA sterile, IIB and III class medical devices.

The regulation established nine months (i.e. until 1 June 2023) transition period. Within this timeline, registration and amendment procedures may be done with submission of ISO 13485 inspection report on condition that postponed inspection to be performed by the Russian component authority within 2 years after approval.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in July 2022

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  1. New Revision of the Eurasian Medical Device Registration Rules

On 18 July 2022, the Decision of the Eurasian Commission #144 (link in Russian) came into force, implementing several significant changes in the current Eurasian medical device registration rules:

  • Updated criteria for grouping of products in one application for registration not linked with nomenclature code (see clause 19);
  • Clarified requirement to have at least one Eurasian acceptance state  in addition to reference state for registration application (see clause 16 and 21);
  • Updated requirement on list of administrative documents (e.g. mandatory contract between Manufacturer and Eurasian authorized representative – see Annex IV clause 3);
  • Updated terminology: “components”, “consumables” have been replaced with terms “composition” and “accessories”;
  • Updated requirement on QMS inspection for sterile 2a, 2b and 3 class devices henceforward may be done within 45 days after start of expert review after possible deficiencies of expert body are resolved but not before the submission (see clause 26);
  • Introduced a possibility for certain amendments in registration licenses to be done as notification without review of the competent authority (see chapter VI);
  • Some other changes.

For the end of July 2022, there are 10 medical devices registered according to the Eurasian regulations.

2. Discussions on Further Prolongations of the National Registration Procedures in Russia

 In June 2022, the Eurasian commission confirmed a prolongation of the transition period from the national to Eurasian medical dveice regulatory system and re-opened submissions on medical device registration according to the national requirements until the 31 December 2022.

In July 2022, the Russian Ministry of Health, in the response to the request from the manufacturers and distributors, admitted a possibility of the further extension of the national procedure for registering medical devices until the end of 2023.

According to the response of the Regulator, this initiative is currently being discussed internally, and the draft protocol with possible amendments will be considered by the Eurasian member states at the next meeting of the Council of the Eurasian Economic Commission.

3. Simplified Registration for Eurasian Manufacturers in Belarus

On 9 June 2022, the Belorussian Ministry of Health released the regulation #52 (link in Russian)
which provided an opportunity for medical devices manufacturers located within the Eurasian Union and having their products approved in USA and European union to pass simplified registration process in Belarus (i.e. without hygiene tests, clinical trials, and production inspections).

The same regulation introduced a new supplemented sub-clause (see 5.2.4) regarding regulation of research-use only (RUO) products in Belarus.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union – June 2022

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  1. Re-opening of medical device registration submissions according to the national requirements

In January 2022, the Russian medical device regulator Roszdravnadzor, as well as regulators of other Eurasian member states, announced the closure of submissions for medical device registration files complying with the original national regulations due to the end of the transition period established by the Eurasian Agreement on common principles of circulation of medical devices.

However, since December 2021 there were active discussion on potential prolongation for another year.

Thus, finally, in June 2022, the Eurasian commission confirmed a prolongation of the transition period and re-opened submissions on medical device registration according to the national requirements until the 31 December 2022.

For the end of June, submissions are open in Russian, Kazak and Belorussian medical device regulators.

Meanwhile, according to the Eurasian database there is information about 8 medical devices approved and more than 50 dossiers submitted for registration according to new Eurasian requirements.

2. Simplified Registration Process for medical devices in risk of shortage

On 1 April 2022, the Russian government released the resolution #552 (link in Russian) and introduced several new, simplified and accelerated paths for registration of medical devices included in the special list in order to deal with a potential shortage of medical devices as a response to economic sanctions.

In June 2022, Roszdravnadzor published two editions of the list, which includes more than 1500 nomenclature codes of medical devices.

According to the new procedure, registration of non-sterile class I medical devices included in the list(s) may be done within five days based on the assessment of administrative documents, in condition of performing the testing  within 50 days and submission of other documents within 150 days after approval;

Registration of medical devices of all classes included in the list(s) may be done based on shortened review and simplified of certain requirements for clinical trials and product testing.

According to the resolution #552, the simplified registration procedures will be open and registration certificates issued according to this process will be valid until 1 September 2023.

3.Update of the Eurasian Technical Regulation on Electromagnetic Compatibility

On 10 June 2022, the Eurasian Economic Commission published a Decision # 91 (link in Russian) and excluded medical devices from the scope of the technical regulation of the Customs Union on TR 020/2011 on the electromagnetic compatibility of technical devices. Over the last years, certification to this regulation was often requested by Customs authorities of Eurasian member states in addition to medical device registration.

Recent Impact of Economic Sanctions on Russian Medical Device Regulations

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While a number of global companies have limited their activities in the Russian Federation, in April 2022, the Russian government released several regulations “intended to improve the stability of the market for socially important goods and mitigate a risk of inventory shortage for medical devices caused by the economic restrictive measures imposed against Russia”.

On 1 April 2022, the Russian government released the resolution #552 (link in Russian) and introduced the possibility of the “fast track” registration for medical devices included the special list. The list of devices (which is not yet available for the 13 of April) to be approved released and maintained by the special commission.

Main updates introduced for registration of medical devices of all classes included in the list:

  • Simplified structure of the registration dossier, a technical dossier may be submitted on behalf of the Russian authorizes representative;
  • Clinical trials/assessment procedure in Russia is not required in case when a medical device is approved in the country of origin;
  • Shortening timelines for the review: the formal overall registration timeline for this procedure is 22 days including 15 days for dossier evaluation and 7 days for the decision on registration with potential 30 days “stop-watch period” to reply on possible deficiency letter;
  • Registration approval is granted in this case until 1 September 2023 and may open the possibility for “standard” registration without any limitation in expiration date.

Highlights for registration of non-sterile class I medical devices included in the list:

  • Registration review may be done within five days (formal timelines) based on the assessment of administrative documents;
  • Other documents of the registration dossier including test reports to be submitted within 150 days after approval;
  • Mandatory submission of the sample of the device for the testing within five days; and performing the testing within 50 days after approval.

    In addition to the “fast track” medical device approval process, the following regulations have been released over the last month:
  • Government resolution #311 (link in Russian) imposed ban for export of certain medical devices included in the special list from Russia;
  • Government decree #506 (link in Russian) legalized a “parallel importing” in Russia for certain goods including medical devices without the permission of the trademark holder;
  • Federal Law #64 – FZ (link in Russian) obliged manufacturers and importers of medical devices to notified the regulator prior to suspend or terminate their activity in Russia;

Russian healthcare regulator Roszdravnadzor announced a regular meetings with foreign medical devices manufacturers with a purpose to discuss “the ways of further cooperation” and  cancelled until the end of the year scheduled and un-scheduled audits.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union – February 2022

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  1. Mandatory notification on all imported medical devices since March 1st, 2022

 March 1st, 2022, is the date of enforcement of regulation #11020 (link in Russian) establishing mandatory requirements to notify authorities for every unit of any medical device imported into Russia, as well as manufactured within the country.

According to the regulation, this notification has to be performed for the purpose of safety monitoring by the regulatory agencies. It should be done by the manufacturer, its authorised representative or the importer of a medical device. Information regarding the name of the medical device and its modification, its serial number, its manufacturing and expiration date and the number and date of registration should be submitted using the Roszdravnadzor electronic system within fifteen days of importation or manufacturing release of a product.

2. New guidance on quality management system requirements for the registration of medical devices

On February 9th, 2022, the Russian government released regulation #135 (link in Russian) and established rules for the inspection of quality management systems for medical device manufacturers. The document introduces mandatory requirements to submit QMS inspection reports using national procedures for any amendment to registration certificates from June 1st, 2023, and provides detailed guidance on the organisation of the QMS audit.

In addition, on February 18th, 2022, the Russian Ministry of Health released regulation #91N (link in Russian) on methods for determining the amount of payment for the provision of services related to the inspection of the production of medical devices. The document provides tools to calculate required human resources and costs for the inspection of quality management systems for the registration of medical devices.

According to the document, the maximum cost for an inspection is limited to 1.274 million rubles including VAT for Russian manufacturers (approximately 13,000 USD) and 2.729 million rubles for foreign manufacturers (approximately 28,000 USD).

3. New guidelines for pre-clinical and clinical testing for medical devices in Russia


March 1st, 2022, is also a date of enforcement of regulation # 885N (link in Russian) with a new revision of the guidelines for technical assessments, toxicology testing and clinical trials as part of the national registration procedure of medical devices. The regulation will replace regulation #2N (link in Russian) that was effective since 2014.
It should be recalled that the possibility of reopening submissions according to national registration rules for another year has been debated since the end of December 2021. However, as of the end of February 2022, this remained impossible.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2022

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  1. Submissions according to the local medical device regulations of the Eurasian member states are closed, but may reopen

According to the Eurasian agreement on the common principles and rules of circulation of medical devices, 1 January 2022 is the end of the transition period for device registration to move from national to the Eurasian level. 

On 30 December 2021, the Eurasian Economic Commission (EEC) released this protocol (link in Russian) confirming the transition and that all registration dossiers submitted before 31 December 2021 must be reviewed using the original rules. The protocol also confirmed that all medical devices approved locally in Eurasian states before 31 December 2021 could keep their status in the member state until their registration expires. The registrations could also be amended to comply with national rules, which are valid until 31 December 2026.

In January 2022, the Russian medical device regulator Roszdravnadzor announced the closure of submissions for new device registration files complying with the original national regulations. Medical device regulators also published same information in Kazakhstan and Belarus. 

However, on 24 December 2021, the EEC discussed new changes to the agreement, a potential reopening of submissions, and prolonging the transition period for another year. On 19 January 2022, the EEC published Decree 27 (link in Russian) approving this extension which all Eurasian member states should authorize.

In addition, at the end of December 2021, two amendments to existing Eurasian medical device regulations were released by the EEC: Regulation 144, a revision of EEU rules for device registration and examination (link in Russian), and regulation 146, a new edition of the guidance on clinical trials (link in Russian).

At the end of January 2022 there  still  7 medical device approved on the Eurasian database according to new requirements, while the Russian Regulator was saying about hundreds of new submissions per day according to the national requirements for the end of 2021 and more than 31 thousand medical devices approved  on “old approach”.

  1. Upcoming Deadline for submission of clinical monitoring reports in Russia

According to regulation 1113 (link in Russian) that came into force in January 2021, clinical post-market monitoring is now required for class III medical devices and IIB implantable devices registered in Russia afterJanuary 2021. The regulation also states that devices should be continuously monitored, with annual monitoring reports for three years after the approval date. Guidelines for the structure and content of the reports are provided in annex 5 of the regulation.

The deadline for submission of the first reports is 1 February 2022. 

On 21 January 2021, Roszdrvnadzor published a reminder for medical device manufacturers (link in Russian) and clarified the report submission requirements on paper.

3. Extension of the accelerated approval route for medical products for diagnosing and treating COVID-19

In December 2021, the Russian Government released regulation 2250 (link in Russian) and extended until 1 January 2025 the accelerated approval process for COVID-19 diagnostic and treatment products.

According to regulation 430 (link in Russian), more than 400 such medical devices may be approved via the expedited evaluation route with a limited expiration date for a particular batch.

More than 500 existing registration certificates in the national database issued via this route had their validity extended from 1 January 2022 until 1 January 2025;

In January 2022, the Russian regulator confirmed it is possible to submit these registration files using Russian national (but not Eurasian ) criteria. 

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Thank you for following my blog, which aims to provide timely and clear updates on the development of Russian and Eurasian medical device regulations. You may also be interested in my recent article on the Eurasian medical device regulation model, which will be published in the Journal of Medical Device Regulation in February 2022.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, November 2021

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Dear Colleagues, 

Welcome to my monthly review of regulation changes regarding medical devices in Russia and the Eurasian region.

  1. Eurasian transition in less than a month

In less than a month the transition period will end and the complete switch to the Eurasian medical device regulations will come into effect. Applications for registration of medical devices under national requirements for Russia, Belarus and Kazakhstan will be closed. From 1 January 2022 all medical devices must be registered solely according to the laws of the Eurasian Economic Union (EAEU). 

After the five-year transition period, very limited practical experience of working under the new requirements has been acquired:As of November 2021, the Eurasian Commission (EEC) listed seven approved medical devices on its official register, and more than 30 applications are currently under review by the Eurasian member states.

It should be recalled that Eurasian Regulation #142 (link in Russian) dated September 2019, Eurasian Regulation #20 (link in Russian) dated 21 October 2021 and Russian Regulation #2081 (link in Russian) dated July 2021 established the following requirements for this transition:

-Submissions for registration and expertise of medical devices (according to national procedure in Russia, Belarus, Kazakhstan and Kyrgyzstan) are permitted until 31 December 2021.

-Medical devices approved under local registration systems in Eurasian member states by 31 December 2021 may keep this status in the member state until the registration expires, with the possibility of amendment according to the national rules, which are valid till 31 December 2026.

If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of the member state in question.

As of the end of November 2021, no other official updates on changes, extensions or exemptions to the requirements were published. However, the requirements should also be ratified by all Eurasian member states.

2. Mandatory Notification on All Imported Medical Devices in Russia

On 25 November 2021, the Russian ministry of health published a regulation # 11020 (link in Russian) and established since 1 March 2022 a mandatory requirements for notification on every unit of any medical device imported in Russia or manufactured within the country for the purpose of safety monitoring by the regulator. According to the document, information on the name of the medical device and its modification, its serial number, its manufacturing and expiration date and the number and date of registration should be submitted using the Roszdravnadzor electronic system (Russian medical device regulator) within fifteen days after importation or manufacturing release.

3. Requirements on certain in-vitro diagnostics products 

On 2 November 2021, the Russian ministry of health published Order #1031N (link in Russian), which approved the procedure for the manufacture, storage and disposal of certain medical devices for in vitro diagnostics (IVD) (i.e. ‘in-house/home-brew’ IVD assays) developed and manufactured by individual laboratories.

It should be recalled that, according to the regulations accepted in July 2021, certain products may undergo an accelerated approval process to receive a special five-year permit for clinical/diagnostic use, in particular laboratories without registration of a product. 

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, October 2021

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Dear Colleagues, 

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

1. New rules for Russian state register of medical devices

On 30 September 2021, the Russian government released Resolution 1650 (link in Russian), ‘On approval of the Rules for maintaining the state register of medical devices’, which, since 1 March 2022, implements new requirements for the Russian state register (the database of approved medical devices).

According to the published regulation, in addition to the information, which is currently available in the database, the updated state register will contain registered instructions for use, photos of the device or software interface as well as information on analogue (substitutable) medical devices.

2. Prolongation of the accelerated registration routes for medical devices intended for diagnosis and treatment of COVID-19

On 28 October 2021, the Russian Ministry of Health released draft amendments (link in Russian) to Resolution 430, which suggested prolonging, from 1 January 2022 to 1 January 2025, the validity of registration certificates for particular batch/lots if the medical devices and in vitro products were intended for diagnosis and treatment of COVID-19. Such certificates were issued according to the accelerated registration procedure. For such a prolongation of the licenses, the registration holder has to submit documents for the procedure of administrative replacement by 1 January 2022.

It should be noted that, for the end of October 2021, there are more than 600 registration certificates in the national database that were issued according to this route and potentially may be prolonged.

The same published draft document extends the possibility of submitting new batches of medical devices for the accelerated registration procedure to 1 January 2025 (instead of 1 January 2022), regardless of the approaching transition to the Eurasian medical device registration system.

In addition, the published regulation expanded, from 360 to 470, the list of medical device products intended for emergency use in the prevention and treatment of coronavirus infection, which fall under the simplified accelerated registration process.

3. New state fees for registration of medical devices in Russia and the Eurasian Union

At the end of September 2021, the Russian government released a draft amendment to the Russian tax code (link in Russian) suggesting an increase in the level of state fees for registration of pharmaceutical products and medical devices in Russia and the Eurasian Union, as of the beginning of 2022.

According to the document, the new amount for registration expertise will vary, depending on the risk class of the medical device, from 72,000 to 184,000 rubles (app. 1,000–2,500 USD). The level of expertise required for amendment of the registration certificates will incur a cost also, from 32,000 to 104,000 rubles (app. 500–1,500 USD).

The fees for the new procedure for getting authorisation for use for certain non-registered in vitro products is expected to be 65,800 rubles (app. 1,000 USD).

According to the published draft regulation, the same level of fees will apply for the expertise and acceptance procedures for Eurasian medical device registration.