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, 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 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.

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

Dear Colleagues, 

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


1. Suggestions for Multiple Amendments to Russian Medical Device Regulations

In April 2021, multiple amendments made to Federal Law #323 ‘On health care protection’, related to the regulation of medical devices, were discussed by the Russian parliament. The published draft law (link in Russian) related to this initiative, among others, proposed the following significant changes to Russian medical device regulations:

– to amend the list of cases where medical devices are not subject to state registration;

– to implement the procedure for approving the classification of adverse effects of monitoring the safety of medical devices;

– to clarify the definition of ‘poor quality medical device’;

– to establish requirements for the implementation, maintenance and assessment of a quality management system for the production of medical devices;

– to establish a requirement to reissue licenses for the technical maintenance of medical device manufacturers by 31 December 2022;

– to grant the possibility of circulation of medical devices according to technical documentation in cases when registration certificate is expired and after 180 days in case of amendment of the registration certificate.

At the end of April 2021, the document was approved by the Russian parliament and signed by the President, although it has not yet come into force.

2. Discussions on the Simplification of Registration for Russian Manufacturers

Another initiative that was discussed and proposed by the Russian government over the last month was draft regulations (link in Russian), suggesting the simplification of the national registration process (an accelerated one-step registration) for Russian manufacturers. This would be on the condition that performance type testing, overseen by Russian healthcare regulator Roszdravnadzor, is carried out in the testing lab of the expert body.

The same draft proposed the possibility of two additional request/deficiency letters from Roszdravnadzor during the national Russian registration procedure (instead of one request as it stands currently) to minimise the possibility of registration rejections.
By the end of April 2021, the document had reached public discussion.

3. Development of Regulations on Remote Quality Management Audits for Medical Device Manufacturers

On 30 April 2021, the Eurasian Commission published a draft document (link in Russian) on the amendment of the Eurasian Requirements for Quality Management Systems for Manufacturers of Medical Devices (which were previously implemented in the Eurasian Regulation #106).

According to the proposed amendments in the draft document, the quality management audit (required for Eurasian approval of medical devices classed as high risk) may be performed in remote mode with approval from the regulator and on the condition that there will be a standard audit within two years of the virtual inspection.

The draft document is expected to be in public discussion until the end of May 2021.

Earlier in April 2021, the Russian Agency on Technical Regulating and Metrology released the national standard GOST 59424-2021 with guidelines for performing remote analysis of the management system.

The QMS audit is a mandatory step for the approval process of IIb and III class devices, according to Eurasian regulations. Due to travel restrictions caused by the pandemic and a lack of clear guidance, however, switching to Eurasian approvals remains highly uncertain for manufacturers. 

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

Dear Colleagues,

Here is my regular update on the Russian and Eurasian medical device regulations for the last month:

  1. Update on the Eurasian Transitional Period

On 9 March 2021, the Eurasian Commission published Regulation No.28 (Link in Russian) which confirmed and specified deadlines for the Eurasian regulation transition period previously established  as follows:

  • Submissions for registration and expertise of medical devices according to the 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 according to the local registration system in the Eurasian member states may stay approved in this member state by the end of validity of the registration.
  • Registration certificates for medical devices registered according to the local rules may be amended (by the local rules) by 31 December 2026.

On 22 March 2021, the Russian Ministry of Health published the draft of amendments of the rules for the state registration of medical devices in Russia (link to the draft in Russian), harmonised with Eurasian regulations and transition deadlines and proposed other amendments. The draft is currently in the discussion stage until 9 April 2021.

Regardless of the approaching end of the transition period, we still may see a limited number of submissions and approvals according to the new Eurasian system.  As of the end of March 2021, there are five records concerning approval of medical/in-vitro devices in the Eurasian Union. All approved devices are manufactured by Eurasian manufacturers.

  1. Extension of the Restriction List for Medical Devices in Russia

On 6 March 2021, the Russian Government released Resolution No.336 (link in Russian), which expanded the list of medical devices originating from foreign countries, subject to restrictions for state and municipal procurements according to Resolution #102.

The new devices added to the restriction list include biochemical analysers, fetal monitors, medical, biological, and clinical microscopes for laboratory diagnostics, ultrasound surgical devices, surgical coagulants, and therapeutic laser devices.

According to Resolution #102, participation in government and municipal tenders for the supply of these products must be rejected if at least two suppliers from Russia or the EAEU countries take part in the auction with a similar type of product.

  1. Kazakhstan Updated Labelling and Advertising Requirements for Pharmaceutical Products and Medical Devices

At the end of February 2021, the Ministry of Health of Kazakhstan released order #KR-DCM -11 (link in Russian) and updated national requirements for the labelling of medical devices. The regulations provide a list of information and symbols required for the manufacturer to state on the label of a medical device. The labelling must be present in Russian and Kazak languages, approved by the competent authority during the registration process and attached to each unit.

Previously, in January 2021, the Ministry of Health of Kazakhstan enforced the order #KR-DCM -11 (link in Russian) and updated rules for advertising medical devices in the country.

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Russian and Eurasian Regulatory Roundup of 2020

Russian and Eurasian Regulatory Roundup of 2020

Dear Colleagues,

2021 is approaching, and in my usual December post, let me look back and summarise the highlights and major updates on medical device regulations in Russia and the Eurasian Union in the year 2020.

  1. Eurasian Medical Device Regulation Highlights 2020:

A year ago, on 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced that the first medical device was approved under the Eurasian medical device regulations. The first Eurasian registration certificate was issued for a 2A class neonatal phototherapy lamp that was manufactured in Russia.

By the end of December 2020, there have been four medical devices (in-vitro devices) mentioned in the Eurasian database – all of these manufactured by Russian manufacturers. In the same database, we can also notice over 30 files submitted for Eurasian registration between 2019 and 2020 (with a significantly high rejection rate and a review time of over 350 days).

One of the key challenges for manufacturers (especially during the time of travel restrictions imposed during the pandemic) has been the necessity for carrying out an inspection of a manufacturing site to ensure compliance with quality management system (QMS) requirements (in accordance with the Eurasian Regulation #106). This compliance, as per regulations, is a mandatory step for approval of any medical device belonging to classes IIA and III. However, in September 2020, Roszdravnadzor announced that the first QMS inspection was carried out on the first medical device and that its approval was provided by complying with the Eurasian medical device registration procedure. Roszdravnadzor also announced that it carried out manufacturing inspection of two manufacturing sites located in Russia.

Most of the 1st, 2nd and 3rd level Eurasian regulations, nowadays, are released and approved by the Eurasian Commission. Some of the regulations that were updated over the course of 2020 include the amendment to the rules of registration and examination of medical devices (link in Russian), draft of a regulation on technical testing requirements (link in Russian), draft regulations on amendments to the criteria for classifying products as medical devices (link to the draft document in Russian).


According to Decision #142 (published in September 2019), the end of the transition period for submissions, according to local regulations of the Eurasian member states, as of today, still remains 31 December 2021.

  1. Russian Medical Device Regulation Highlights 2020:
  1. Response to COVID-19 – Russian and Eurasian Medical Device Regulations:

In the year 2020, the COVID-19 pandemic has overwhelmed the Russian healthcare system (which has been the case with other countries too). In response to the pandemic, Russian Ministry of Health introduced certain new regulatory measures and approval pathways related to medical devices and in-vitro diagnostics:

  • On 18 March 2020, the Russian government released Resolution #299 (link in Russian) followed by methodical guidelines (link in Russian) and opened a simplified registration route for 36 types of class I protective medical devices, including surgical or protective face masks, respirators, medical protective clothing, surgical suits, medical gloves, overshoes, etc. The official timeline for taking a decision on registration of products that are included in the list is within five days upon receipt of the registration file, on the condition that the manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trial reports) within five months of the approval date. By the end of the year, the regulator announced that the initial registration of 1342 medical devices that were approved through the accelerated and simplified registration route were withdrawn since the required documents were not provided within the established deadlines.
  • On 6 April 2020, the Russian government released Resolution #430 (link in Russian) followed by guidelines (link in Russian)  and introduces simplified accelerated registration process for temporary approval of particular batches of 108 types of medical devices and IVD products included in the list (this list was extended to 363 types of products )that were intended for emergency usage in the prevention and treatment of coronavirus infection.
  • The temporary registration certificate (validity of which was prolonged until the end of 2021) of the product included in the list may be granted by Roszdravnadzor (within three business days) after carrying out testing through the special accelerated program).
  • By the end of December 2020, there will be over 300 registration records (for particular bathes) holding a temporary registration certificate in the Russian registration database.
  • Additionally, since April 2020, the regulator has allowed to sell imported disposable medical products included in the list (and not registered in the Russian Federation) on the condition that these products are registered in the specified manner outlined by the manufacturing country.

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    I would like to thank all of my subscribers and readers for showing your continuous interest and feedback  in my posts and updates. I wish you a wonderful holiday season! All the very best for the year 2021!

Three Things You Should Know about Medical Device Regulations in Russia and Eurasian Union, November 2020

Dear Colleagues,

Here is my usual selection of highlights to keep you in the loop regarding updates in Russian and Eurasian medical device regulations for the last month.

  1. Prolongation of the Simplified Medical Device Approval Process in Russia


On 13 November 2020, the Russian government released Resolution #1826  (Link in Russian) extending the validity of the simplified batch-by-batch approval process for medical devices and IVD products intended for emergency use in the prevention and treatment of coronavirus infection introduced in April 2020, for one year (i.e. until the end of 2021).

The published resolution can also extend the validity of licenses that were issued according to this simplified procedure, for particular batches of the products. However, this extension will require the procedure of the administrative replacement.

As of today, the simplified batch-by-batch approval process is valid for 363 types of medical devices, including some IVD assays and laboratory consumables, artificial ventilation machines and breathing circuits, connectors and valves for mechanical ventilation, pulse oximeters, patient monitors, medical furniture, protective masks and other medical devices and protective equipment. There are 278 registration certificates that were issued through this process.

2. Updated Procedure for Safety Monitoring of Medical Devices in Russia

On 2 November 2020, the Russian Ministry of Health published the Order #980n on the approval of the procedure of the safety monitoring for medical devices (link in Russian).
The regulation, that replaced the previous obsolete order cancelled in July 2020, comes into force on 1 January 2021 and will be applicable for medical devices approved according to Russian local procedure until 1 January 2027.

The Russian medical device regulation, requires licence holders to perform safety monitoring  by collecting information ‘on adverse effects not specified in the operating manual of the medical device, adverse reactions during its use, the peculiarities of the interaction of medical devices with each other, facts and circumstances that pose a threat to the life and health of citizens and medical workers during their use and operation.’

According to the document, the Russian medical device regulator may receive the information on adverse events from the reporting of manufacturers of medical devices, as well as by monitoring the post-market surveillance databases of regulatory agencies of other jurisdictions or control measures performed by the regulator.

Based on the information received during safety monitoring, the regulator may initiate additional control measures or request a plan of corrective action from the manufacturer.

3. Eurasian Criteria for Classifying Products as Medical Devices

On 24 November 2020, the Eurasian Commission published draft regulations on amendments to the criteria for classifying products as medical devices within the Eurasian Economic Union.  (link to the draft document in Russian)

The document proposes changes to existing criteria, issued in 2018 in Regulation #25, in order to eliminate differences in the requirements for classifying products as medical devices between the  Eurasian regulations and local regulations of the member states.
Most of proposed changes relate to standardising criteria for medical software with recently updated Russian requirements and some protective equipment.

The draft document is open for public discussion until 25 January 2021.

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Three Things You Should Know About Medical Device Regulations in Russia, September 2020

Dear Colleagues,

Here is my regular update on the Russian and Eurasian medical device regulations for the last month:


1. Updated Criteria for Medical Devices Exempted from the Registration Requirement


On 1 September 2020 the Russian government released Resolution #1335 (link in Russian) and updated the criteria of medical devices that do not require registration in Russia. The regulator also harmonised these requirements with the Eurasian legislation.

Henceforward, the following medical devices are within the scope of this regulation:
–Medical devices that match the Eurasian criteria listed in Clause 4.11 of the Eurasian Agreement (including medical devices for personal use, medical devices for medical aid on transport or international cultural or sport events, as well as those imported for humanitarian use);
–Custom-made medical devices that are made and intended for a particular patient;
–Medical devices that are intended for use within the territory of the international medical cluster or innovative science and technology centres.

2. First Medical Device Passed Eurasian Quality Management Inspection

Russian healthcare regulator, Roszdravnadzor, announced on 16 September 2020 the approval of the first medical device according to the Eurasian medical device registration procedure including the completed manufacturing inspection of two manufacturing sites (located in Russia) for compliance with the quality management system requirements according to Eurasian Regulation #106.

It should be recalled that since March 2019, after a one-year transitional period, the quality management inspection system became a mandatory step for the Eurasian approval of medical devices of IIB–III risk classes; however, until today, many of the organizational and administrative requirements for such inspections, as well as the list of the organisations that conducted these inspections, were not clear.

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.

At the end of September 2020, there are four medical/in-vitro devices in the Eurasian database, all of them manufactured by Russian manufacturers.

3. Upcoming Deadline for the Administrative Replacement of the Obsolete Licences

In September, Roszdravnador reminded the industry that Russian registration certificates for medical devices issued before 2013 and having unlimited validity must be updated according to the special administrative replacement procedure by 1 January 2021; otherwise, after this deadline these licences will be annulled by the regulator.

The requirement to update old licenses was introduced in 2013, when Russia enforced a new medical device regulation system, and, after that, in 2017 the deadline for replacement was prolonged until 2021;

A detailed description of the replacement procedure is provided on the official site of Roszdravnadzor (in Russian) or here.

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Thank you for following my blog, which is the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. For Russian and Eurasian updates you might also be interested in my upcoming seminar or presentation on the MedTech summit.

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

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

 

  1. Development of the Regulations for Software as a Medical Device (SaMD) and Artificial Intelligence

On the 10th August 2020, the Russian Ministry of Health published order #686N (link in Russian) and updated the algorithm for the classification and registration of SaMD.

In addition, in early August 2020, the Russian Ministry of Health published two draft regulations:

  • An amendment to the rules governing the state registration of medical devices (link in Russian) suggesting an accelerated approval process (a one-step registration instead of the current two-step process) for SaMD, including software that uses ‘artificial intelligence technologies’.
  • An amendment to the requirements for technical files and the instructions for their use (link in Russian), providing specific requirements in relation to the technical files for SaMD.

It is interesting to mention that at the end of July 2020, the Russian Ministry of Health announced that work to improve the standards of artificial intelligence in healthcare was underway, and in the last month it has been revealed that a first draftof the national standard on clinical trials for systems with artificial intelligence has been published.

Regular readers might also recall that in June 2020, the Russian healthcare regulator Roszdravnadzor published the updated guidelines (national methodical recommendations) for the registration of SaMD in Russia (link in Russian).

The accelerated approval process for the registration of low-risk medical devices (class I) and in vitro diagnostics was implemented in Russia in 2018.

  1. List of Medical Devices Containing Ethyl Alcohol

On the 26th August 2020, Roszdravnadzor published (link in Russian) a list of 41 medical devices containing ethyl alcohol that are excluded from general alcohol regulations in Russia, such as Federal Law 171. The production, importation and circulation of these products will not be covered by the federal law on the regulation of ethyl alcohol and thus will not require additional licenses or permits.

According to the current procedure, this list is created using applications from manufacturers, or their authorized representatives, submitted to Roszdravnadzor between the 1st of January and the 30th of June each year, and subject to rules that came into effect in 2019.

It should also be noted that Russian legislation specifies that any medical device in liquid form containing ethyl alcohol (ethanol) should be subject to additional specific regulation.

  1. Eurasian Update

On the 3rd August 2020, the Eurasian Commission published a draft regulation with an amendment to the rules for toxicology (biocompatibility) testing of medical devices for Eurasian registration (link to the draft in Russian).

This document included updates to the testing requirements and the description of the testing procedure. The regulation also updated the criteria for the inclusion of testing laboratories into the unified Eurasian database.

For the end of August 2020, according to the official website of the Eurasian Commission, there were three medical devices approved using the Eurasian procedure with more than 20 applications for Eurasian registration submitted by manufacturers over the last year, and 23 laboratories now accredited to perform the testing.

 

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Thank you for following my blog, which is a non-commercial project with the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. Let me remind you that you can receive my regular updates directly to your email via the ‘follow’ button on the toolbar of this blog.