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

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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.

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

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Dear Colleagues,

Here is my usual list of highlights on the updates and developments of medical device regulations in Russia:

  1. Expanded List of Medical Devices for Accelerated Registration

On 2 June 2020, the Russian government released the Resolution #804 (link in Russian) and expanded the list of medical devices falling under the simplified accelerated registration process of medical devices and in vitro products intended for emergency use in the prevention and treatment of coronavirus infection (introduced in March 2020). The temporary registration certificate (valid until the end of 2020) for particular batches of such devices may be granted by the Russian healthcare regulator, Roszdravnadzor, within three business days after submission of the dossier.

As of today, there are 363 types of medical devices in the Resolution #804 list, 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.

Single-use medical devices included in the list may be imported into Russia and put on the market without registration in the condition they were approved in their country of origin, and information on batches imported into Russia is submitted to Roszdravnadzor.

The resolution also provides the new procedure for the renewal and amendment of temporary registration certificates.

  1. Updated Guidelines for Medical Software Registration in Russia

On 9 June 2020, Roszdravnadzor published the updated guidelines (national methodical recommendations) on the registration of software as a medical device in Russia (link to the document in Russian).

The document contains criteria on which software may be considered a medical device (with examples), a classification algorithm with a reference to the Russian GOST standard, requirements on technical documentation for software in Russia, references to the legislation on personal data and other legal requirements, as well as an algorithm for technical testing, clinical trials and assessment by the competent authority.

To be recalled, that on February 2020, Roszdravnadzor already published the letter clarifying some of these topics.

  1. Batch Notification Requirement for Medical Device Importers in Russia

A relatively new initiative for medical device regulations in Russia is the requirement of manufacturers and importers to notify Roszdravnadzor of every series and batch of medical devices imported and circulated in Russia. The order to introduce the draft law ensuring this requirement by 15 July 2020 was done by the Russian President, Vladimir Putin, on 24 June 2020. According to the order, a data analysis should be done for information on monitoring the safety of medical devices (post-market surveillance).

 

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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. You can receive my regular updates directly to your email via the ‘follow’ button on the toolbar of this blog.

 

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

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Dear colleagues,

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

  1. Updated Criteria for Software as Medical Devices in Russia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Dear Colleagues,

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

1. Updates in Medical Device Control Procedures in Russia

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

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

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

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

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

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

3. Simplified Approval Path for Refurbished Medical Devices in Belarus

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

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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 from your email via the ‘follow’ button on the toolbar of this blog.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, September 2018

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Dear Colleagues,

Here is my usual monthly selection of news about developments in medical device regulations in Russia and countries of the Eurasian Economic Union for September 2018.

  1. Kazakhstan Changes the Rules for Registration Examination of Medical Devices

At the end of August 2018, order #347 of the Ministry of Health of Kazakhstan (link in Russian) came into force and implemented multiple amendments to the rules of examination (expertise) of medicines and medical devices for registration according to the local procedure. 

Order #347 provides updated requirements for the content of the registration dossier, samples for testing, and the procedure for conducting the examination for registration. The expertise process for registration of medical devices consists, as before, of three steps (validation of the registration documents, laboratory testing, and specialised expertise), which take up to 90 working days of real time for I and IIA class devices and up to 160 working days for IIb–III class devices.
In the new edition of the rules, we notice the harmonisation of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.
The new rules also stipulate the possibility of obtaining pre-registration consultancy from the expert organisation.
New requirements have been effective for all medical device submissions for registration and renewals in Kazakhstan since early September 2018.

  1. Russia: Guidelines on Software Registration

On 12 September 2018, Russian medical device regulator Roszdravnadzor published methodological recommendations (guidelines) on the procedure for assessment (expertise) of medical software for its registration as a medical device in Russia (link to the document in Russian).
The published document is intended to establish uniform approaches for the registration assessment of software as a  stand-alone medical device across institutions involved in the medical device registration process in Russia.
The guidelines contain a list of criteria for assigning software to medical devices depending on their intended use, principles for classification and determining the risk category, possible criteria for non-compliance during registration assessment, algorithms for assessment of technical documentation, and a list of national standards used for software evaluation.

  1. Russia to Chair IMDRF in 2019

Russia will replace China as IMDRF (International Medical Device Regulators Forum) chair in 2019; this was announced during the IMDRF meeting in Beijing, China where  the key topics for the next year were highlighted as Cybersecurity, Premarket Reviews, Personalized Device Regulatory Pathways. The upcoming IMDRF meeting in March 2019 was also announced by the Roszdravnadzor management during the industry meeting in September 2018.

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Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer. You can receive updates directly to your e-mail via the ‘Follow’ button on the toolbar.

Three Things You Should Know about Medical Device Regulations in Russia, November 2017

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Dear colleagues and group members,

Welcome to my monthly newsletter with the most important regulatory updates on medical devices in Russia for November 2017.

  1. Russian medical device expert organisations are starting pre-submission consultancy
    In November 2017, both Russian expert organisations involved in the registration process announced the start of pre-submission consultations for medical device manufacturers. The expert organisations published information on consultancy procedures, application forms, contracts, information on prices, and required and recommended documents on their websites:
    – Consultations from VNIIMT (ВНИИМТ) expert organization – link in Russian;
    – Consultations from CMIKEE (ЦМИКЭЭ) expert organization – link in Russian;

    According to Roszdravnadzor Regulation 6478 (link in Russian) published in July and enforced in September 2017, the scope of the consultations are: development of a medical device and necessary documentation and testing for registration and re-registration for particular devices, specific aspects of the Russian registration process and requirements, classification of medical devices, and determination if a product meets the definition of a medical device, according to Russian regulations.

  2. Evolution of restrictions on polyvinyl chloride consumables
    On 1 November 2017, the Russian Ministry of Health published a letter (link in Russian) with information on weighted average prices for disposable medical devices from the government list of foreign disposables made from polyvinyl chloride (PVC) plastics, whose admission to public procurement was restricted by Resolution # 968.
    It should be recalled that Resolution No. 967 (link in Russian) and Resolution No. 968 (link in Russian) came into force in August 2017, and extended the list of medical products restricted from participation in state procurements, (link to up-to-date version in Russian) with particular reference to medical devices containing PVC implementing criteria for its manufacturers, and the new scheme of state procurement for such products.
    The national register for manufacturers of PVC consumables that met the criteria is published by the Russian Ministry of Industry and Trade and at the end of November contains one company.

    3. Medical software in telemedicine technologies

    On 3 November 2017, the Russian Ministry of Health published draft regulations on providing medical care using telemedicine technologies (link in Russian). Amongst other matters, the document contains a requirement for mandatory registration of special medical software that is ‘designed for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body and used as a part of information systems’ as a medical device.

    It should be noted that, the Russian medical device regulator Roszdravnadzor has emphasised several times during the past years that medical software should be considered a type of medical device and must therefore pass the mandatory registration process

Three Things You Should Know about Medical Device Regulations in Russia, January 2016

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Dear Colleagues,

It is the end of the January and I am glad to deliver my monthly update on events in the Russian and Eurasian regulatory landscape.

  1. The Eurasian Market for Medical Devices Formally Came into Force

On 1 January 2016, Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan formally introduced a common market and regulatory system for medical devices within the Eurasian Economic Union (EEU). One of the final steps – ratification by Russian parliament – was completed by the end of January. Some (but not all) second-level regulations have now been officially published and are in force: e.g. new rules on post-market safety surveillance can be found on the website of Roszdravnadzor (the Russian medical device regulator).

From a practical standpoint, there is currently no information about how any regulatory step (testing, expertize, clinical trials, registration submission) should be conducted under the new Eurasian approach, and medical device competent authorities in member states continue to receive registration submissions and grant approvals using “old” local procedures. From 1-28 of January 2016, for instance, 166 medical device approvals were registered in the database of the competent authority in Russia, while 87 approvals were made in Kazakhstan and 149 in Belarus.

Roszdravnadzor has announced a full-day regulatory conference (with online broadcast) on 4 February 2016, where more details and guidance about Eurasian medical device integration are expected to be announced.

 

  1. Evolution of Price Regulation for Implantable Medical Devices in Russia

The subjects of price regulation for implantable medical devices and “destabilization of prices in the market” for state procurements have been discussed by Russian government institutions since the end of 2014, when the Russian Ministry of Health published a list of “implantable medical devices approved for state programmes of guarantees on gratuitous medical care”.
In March 2015, Russia adopted amendments to Article #80 of Federal Law No. 323-FZ (“On fundamental healthcare principles in the Russian Federation”) and introduced regulation of maximum sale prices and maximum volume of wholesale and retail mark-ups for medical devices on the previously published list.
On 9 January 2016, the Russian government published Resolution #1517 (link in Russian), titled “On state regulations of prices of medical devices included in the list”. The resolution came into force on 16 January 2016 and set the methodology for how mark-ups on such devices should be calculated. According to the resolution, prices in future state procurement contracts for implantable medical devices on the list cannot exceed the stated values, including after maximum mark-ups and valued added tax have been calculated accordingly.
In addition, the resolution set a deadline of 15 July 2016 for manufacturers or Russian-authorized representatives to submit files to Roszdravnadzor for price registration.

 

  1. Roszdravnadzor on Medical Software

Roszdravnadzor clarified its requirements for medical software. According to the letter released at the beginning of January (link in Russian), the Russian medical device regulator has informed manufacturers that medical software should be considered a type of medical device and must therefore pass the mandatory registration process if it has any of the following uses: operation of medical equipment, receiving diagnostic data, monitoring and transmitting information on bodily functions (including wireless technologies), calculating dosages for medicines or emissions, medical data management, medical image processing, 3D modelling, or connection of medical and diagnostic equipment. Medical software in Russia, like in many jurisdictions, can be registered as a standalone unit or an integrated part of a medical device.

 

To conclude, I would like to remind that you can follow my updates about Russian medical device regulations on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

Five Questions about Medical Software Regulations in Russia

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  1. Should medical software be registered in Russia?
    Yes, according to clause #2 of Russian medical device registration rules (Decree 1416, link in Russian), special medical software is covered by the definition of a medical device and must be registered prior to market access.
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  1. Should medical software be registered in a separate registration certificate or together with another device for which it is intended?
    Roszdravnadzor (Russian medical device regulator) did not provide clear guidelines on this point up to now. However, if you undertake some brief research in the state medical device register (Roszdravnadzor`s national database of approved medical devices), it is apparent that, since new registration rules were enforced in January 2013, medical software was mentioned in 258 Russian registration certificates. Of this number, absolutely the major part of software was registered as a component or as an accessory to other medical devices (e.g. computerised tomography systems, ultrasound and X-ray devices…). I could find only four cases since this period when medical software was registered as a separate medical product (separate registration certificate).
    It should be noted that, since the beginning of 2015, a new medical device nomenclature classifier has been enforced. In the current version of this classification there are more than 150 codes devoted to medical software depending on its intended use.
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  2. Should a version of software be indicated in the registration submission?
    Roszdravnadzor recommends including the name and the version of the software in the registration application form. Even if medical software is submitted for registration together or as a part of another medical device, its version and release date should be mentioned in the technical file in the registration dossier.  If several versions are mentioned in the description of a medical device, each modification of software should be identified by name, version and release date. Based on recent feedback from the Russian regulator, lack of detailed identification of software is a typical and one of the most common reasons for additional requests and delays during registration expertise in the last year.
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  3. What should be done if the software has been upgraded after a product is registered?
    Upgrade of the software requires notification of Roszdravnadzor (see clause #55 of Decree 1416, link in Russian ). After this notification, then regulator will make a decision; if such an upgrade requires identification of a new software version and if a procedure of revision/renewal of technical documentation of a medical device is necessary. Usually, minor changes and bug fixes will not require further regulatory actions after the notification.
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  4. What are the main regulations?
    -Russian National Standard GOST R ISO/MEC 12119:2000 (link in Russian)
    -Federal Law 102-FZ dated 26.06.2008 (clauses 3.2 and 4.2.5) (link in Russian)
    -WELMEC 7.2 Issue 4 (measuring Instrument Directive 2004/22/EC)