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

  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

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

  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

  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

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

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.

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

Dear colleagues,

Here is my update on the Eurasian Economic Union’s (EAEU) medical device regulations for the last month:

  1. Revision of the EAEU’s Medical Device Registration Rules

On the 21st of September 2021, the Eurasian Economic Commission (EEC) released regulation 148 (link is in Russian) with an updated revision of the EAEU’s medical device registration rules where they implemented significant changes in its requirements. These changes included the option to register several medical devices with different EAEU codes at once, a change of the established timelines for the steps of approval, updates regarding the procedure of amendment of the registration certificate and clarification on the quality management system inspection procedure.

Earlier, on the 13th of September 2021, the EEC released regulation 22 (link is in Russian) with a guide for inspection bodies of the Eurasian member states (EAEU inspectors)  to conduct inspections/audits of a medical device’s manufacturers’ quality management system.

As of the end of September 2021, seven medical devices have been approved under the EAEU rules.

  • Authorisation for Emergency Importation of a Medical Device for Individual Patients in Russia

On the 22nd of September 2021, the Russian Government released resolution 1590 (link is in Russian). This opens the possibility to receive authorisation for emergency importation of medical devices for particular named patients in the case of a life-threatening medical emergency in Russia. Until this moment, this type of emergency importation was not regulated in Russia.

According to the published procedure, this authorisation is valid for 30 days and should be issued by Roszdravnadzor, the Russian medical device regulator, within five business days after the electronic submission of a dossier. A dossier should include the relevant medical justification on behalf of the clinic, identification documents of the patient, the relevant translated instructions for use or user manual and photos of the medical device.

This law will be implemented on the 1st of March 2022 and will be valid until the 1st of January 2027.

  • Updates of the Local Medical Device Registration Procedure in Belarus

On the 1st of September 2021, the government of Belarus released resolution 504 (link is in Russian) updating local medical device registration rules.
The main changes made are related to the registration requirements of medical devices that are needed for urgent needs , used to provide humanitarian aid and supplied by public health organisations as part of international health programs. This resolution also implemented updates on the registration renewal procedure.

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Three Things You Should Know about Medical Device Registration in Russia and the Eurasian Union in August 2021

Dear Colleagues,

Welcome to my monthly review of the most important updates in medical device regulations in Russia and Eurasia:

  1. Strengthening of Import-Substitution Policy for Certain Medical Devices in Russia

On 28 August 2021, the Russian Ministry of Industry and Trade issued Resolution #1432 (link in Russian), which significantly strengthens restrictions on public procurements for a range of over 170 groups of electronic equipment, including more than 30 groups of medical devices manufactured by foreign companies.

The resolution introduced the so-called ‘second odd one out’ rule, which requires public customers procuring products listed in the resolution to reject bids from foreign manufacturers if there is already one (or more) bids for the supply of the same product manufactured in the Eurasian Union. For the medical devices listed in this document, this requirement will replace the similar ‘third odd one out’ rule, introduced by Resolution #102 in February 2015.

In addition, the new regulation requires public customers to obtain permission from the Ministry of Industry and Trade to purchase imported products on the new list.

Resolution #1432 will affect computer tomography, mammography and certain other X-ray machines, certain endoscopic equipment, individual glucometers and glucose analysers, heart rate monitors, ultrasound equipment, inhalation anaesthesia machines and ventilators and some other groups.

2. Russian Regulator Updated Requirements for Importation of Non-registered Medical Devices in Russia

On 9 August 2021, the Russian government issued Resolution #1321 (link in Russian), specifying requirements for importing non-registered medical devices into Russia and the Eurasian Union. These requirements will apply to custom-made medical devices intended for personal use, medical devices imported for research and scientific purposes, medical devices intended for medical assistance during international cultural and sporting events, trade exhibitions and other cases.

According to the published regulation, such imported devices must be reported to Roszdravnadzor via electronic system within three business days.

Regulations allow for the transportation, storage, installation, adjustment, use, operation, maintenance and repair of such non-registered devices, as well as their disposal, destruction and export from the country.

The new order will go into effect on 1 March 2022 and will be valid until 1 January 2027.

3. Updates on Development on Eurasian Medical Device Regulations

There have been several updates to Eurasian medical device regulations over the last month:

At the end of July 2021, the Russian government confirmed (link in Russian) amendments to the Eurasian agreement on common principles of circulation of medical devices regarding deadlines for the end of the transition period, as previously proposed:

-Submissions for registration and expertise of medical devices according to local rules (of the Eurasian member states) will be open until 31 December 2021.

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

-Medical devices approved under the local registration system in Eurasian member states may remain approved in this member state until the registration expires.

-Registration certificates for medical devices registered according to the local rules may be amended (under local rules) until 31 December 2026.

Meanwhile, there is a discussion in the Russian media about a petition from manufacturers and Russian distributors regarding the possibility of extending the submission deadline based on current national requirements.


 On 6 August 2021, the Eurasian Commission published a draft amendment to Eurasian Decision #106 ‘On the requirements for the quality management system for medical devices manufacturers’ (link in Russian), suggesting several updates on the status of the inspection body that performs the audit inspection.

As of the end of August 2021, seven medical devices have been approved under Eurasian rules.

Three Things You Should Know about Medical Device regulations in Russia July 2021

Dear colleagues,

Here is my usual selection of highlights in medical device regulatory updates in Russia over the past month:

1. Implementation of new post-market control measures for medical devices in Russia

On 30 July 2021 the Russian government released Resolution 1066 (link in Russian) and implemented new regulations which significantly changed control measures for organizations involved in the turnover of medical devices in Russia (including manufacturers, distributors and customers [medical centres]).

The document implemented changes in the forms and schedules of the control inspections performed by the regulator. The scheduled inspections will be carried out every 4 to 6 years, depending on the risk classification of the organization, and will not be needed for organizations in low risk groups.

In addition to planned inspections, the document introduced additional control measures such as inspection visits, test purchases and random sample checks of medical devices.

2. Update on quality management system requirements for medical device manufacturers

In July 2021 the Russian government released two draft guidelines on the quality management system (QMS) requirements for medical device manufacturers.

The draft regulation “on requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on their risk classification” (link in Russian) provides a description of the scope of the QMS assessment including design and development, processes for managing documents and records, final inspection processes, corrective and preventive action, and customer-related processes.

The document refers to Russian standard GOST ISO 13485-2017 and Eurasian Decision #106 as guidelines for implementation of the QMS.

Another document published in July 2021 is a draft regulation on conducting QMS inspections of medical device manufacturers (link in Russian).

The published guidance provides differentiation between three types of QMS audits:
1. Initial QMS inspections that must be performed for all manufacturing sites mentioned for registration application.
2. Scheduled regular QMS inspections that must be performed every 5 years for manufacturing sites selected by the regulator.
3. Unplanned QMS inspections that must be performed in certain cases of registration amendments or after completion of corrective actions.

The draft document provides a matrix for the assessment of the significance of the observations recorded during an inspection, which, according to the rules, must be closed within 30 days of the audit.

The document also provides guidance on calculating the duration of an audit, which may vary from 6 to 13 days depending on the headcount of the manufacturing organization. However, the entire inspection process may not exceed 90 days from the submission of the application.

There are several cases for which the regulations allow performing a QMS audit remotely, conditional upon performing an on-site audit within 2 years

3. New regulatory requirements for certain in-home in-vitro diagnostics

On 15 July 2021 the Russian Ministry of Health published a draft regulation (link in Russian) describing new potential approval routes for, as well as regulatory requirements of, certain in-vitro diagnostic (IVD) products (i.e. ‘in-house/home-brew’ IVD assays) developed and manufactured by individual laboratories.

According to the draft regulations such products may undergo an accelerated approval process via the obtainment of a special 5-year permit for clinical/diagnostic use in particular laboratories without registration. The document provides a detailed description of the approval procedure and requirements for submission of an application package.

The procedure is expected to be applicable for IVD products without registered analogue in Russia both made and intended for use by a specific laboratory or organization and will consider an assessment of the financial cost of registration and any existing need for diagnostics using the product.

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

Dear Colleagues,

Please find below my usual selection of the latest updates in medical device regulations in the Eurasian Economic Union (EAEU):

  1. Updates to the List of Eurasian Medical Device Standards

On 8 June 2021, the Eurasian Economic Commission published recommendation #10 (link in Russian) and updated the Eurasian list of standards for demonstrating compliance with essential principles of safety and efficacy of medical devices in the EAEU.

According to the published document, nine existing standards were replaced with more up-to-date versions; eight new standards and one measurement procedure were added, and seven outdated standards were excluded from the current version of the list.

The list of applicable standards to ensure compliance with essential principles of safety and efficacy of medical devices in the EAEU is a ‘third-level’ Eurasian regulation. It was initially published in 2017 and intended to harmonise existing national standards of the Eurasian member states and correlate them with the relevant requirements of the Essential Checklist for voluntary use by manufacturers and testing laboratories during the Eurasian registration process.

  1. Classification of Adverse Events of Medical Devices in Russia

At the end of May 2021, the Russian healthcare regulator Roszdravnadzor released order 4513 (link in Russian) and implemented the classification of adverse events related to the circulation of medical devices.    

The classification contains 27 groups and characterises each of the adverse events that may arise (mechanical, chemical, optical problems, compatibility inconsistency, connection, interaction with the external environment, etc.).

It should be remembered that Russian medical device regulations require monitoring and reporting of medical device adverse events that occur both in Russia and in other countries.

  1. Changes in Tax Regulations for Certain Groups of Medical Devices in Russia

On 1 June 2021, the Russian government published Resolution 851 (link in Russian) and updated the list of medical devices taxed at a decreased rate of 10%, approved by Decree of the Government of the Russian Federation N 688. According to the published document, particular in vitro culture mediums, containers for medical wastes, specific urology devices and medical clothes were included on this list.

Later, on 25 June 2021, the Russian Ministry of Finance gave some clarifications regarding the application of tax preferences on sales of medical devices after switching to the Eurasian system. According to the published letter (link in Russian), the sale of medical devices at the reduced tax rate using a Russian registration certificate will be possible until 31 December 2021. However, according to the same document, the Ministry of Health has already prepared a draft federal law on the abolition of this limitation.

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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 upcoming seminar on this topic, scheduled for July 2021.