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.

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

 

Dear colleagues,

Let me summarise the most important news and updates from the Russian medical device regulatory landscape in July 2020.

  1. Russia Abolished Certain Excessive Medical Device Regulations 

On 4 July 2020, the Russian government published the Resolution 982 (link in Russian) and, in the framework of the so-called ‘regulatory guillotine’, abolished some of the national medical device regulations. 

The most serious changes affected Russian post-market requirements for medical devices (i.e. the cancellation of Regulation 12N on adverse event reporting and Regulation 175N on safety monitoring) and their exclusion from the list of products requiring a GOST certification. 

The published resolution also abolished the regulation on the licensing of manufacturing and technical maintenance of medical equipment and the rules regarding the destruction of counterfeit medical products.

In addition, it will cancel 11 other minor regulations affecting medical devices, starting in January 2021. 

Later, on 29 July 2020, the Ministry of Health published a new draft of a regulation on medical device safety reporting (link in Russian) intended to replace the cancelled regulation. 

The ‘regulatory guillotine’ initiative was announced by the Russian government in 2018 as a measure to cancel the regulatory acts that are no longer effective for the excessive and inefficient regulation of business.

  1. Updated Medical Device Examination Requirements in Russia and Kazakhstan

On 24 July 2020, the Russian Ministry of Health released an updated version of the regulation on the examination of medical devices for their state registration (link in Russian), which replaced its obsolete version.

The document reflects recent changes in higher-level regulations and describes the examination procedures of medical devices (as a part of the registration process) depending on the class of the device or/and the type of submission (e.g. registration of low-class devices, in-vitro diagnostics; accelerated track for medical devices included in the emergency list; examination processes for registration renewals).
Similar changes have recently been implemented in Kazakhstan. The new version of the examination rules, released on 10 July 2020 (link in Russian), allows registration approvals without quality inspections of the manufacturers or/and type testing at the manufacturing sites as a response to the pandemic.

  1. Eurasian Technical Testing Requirements Updated and theSecond Product Approved

On 10 July 2020, the Eurasian Economic Commission published a draft of a regulation on technical testing requirements for Eurasian registration procedures (link in Russian).

The draft clarifies the testing procedures of medical devices for Eurasian registration and the requirements for the accreditation of testing laboratories.

As it was stated in the previous version of the regulation, the objective of technical trials is to demonstrate conformity to Eurasian essential safety and efficiency requirements and standards. The regulations allow testing one ‘typical model’. In cases of groups of similar products and of capital equipment, technical testing may be performed in the countries where the devices are installed. Technical testing is not required for in-vitro diagnostics.

At the end of July 2020, two medical/in-vitro devices have received Eurasian approval.

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

 

 

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, May 2020


Dear Colleagues,

Here is my usual selection of highlights to keep you in the loop regarding updates in Russian medical device regulations:

  1. Accelerated medical device approval tracks in Russia

As you are probably aware from my previous updates,  two accelerated pathways for approval of medical devices were introduced in Russia in response to the coronavirus pandemic over the last few months:

  1. An accelerated track for 36 types of low class medical devices included in the list under Resolution #299 (link in Russian).
  2. Accelerated track for particular batches  for 108 types of medical devices and in-vitro products intended for emergency use in the prevention and treatment of coronavirus infection. The relevant devices are listed under Resolution #430 (link in Russian).

As of 29 May 2020, according to the official database of registered medical devices , there are at least 48 assays for diagnostics of coronavirus infection (molecular assays for detection of the virus and immunochemistry assays for antibody detection) approved in Russia (both accelerated approval for particular and normal registration process; both Russian and foreign manufacturers included).

On May 2020 Russian regulators suggested expanding the list of medical devices appropriate for accelerated pathways.

  1. Restrictions on the procurement of medical furniture, certain protheses and orthopedic devices

On 30 April 2020 the Russian government published Resolution #617, ‘On restrictions on the admission of certain types of industrial goods originating from foreign states for the purpose of procurement to meet state and municipal needs’ (link in Russian). The document introduced a list of goods originating from foreign countries including medical furniture, protheses and certain orthopedic devices which are subject to restrictions for state and municipal procurement. Products in the list are subject to the ‘third odd one out’ rule which states that the public procurement process must exclude foreign manufacturers if at least two bids from local (Eurasian) manufacturers are submitted for tender.

It should be noted that the list of industrial goods introduced by Resolution #617 , a similar list of medical devices was introduced in Russia in 2015 under Resolution #102 (link for current version of the in Russian).

3. Updated risk indicators for control on medical devices

On 8 May 2020 the Russian Ministry of Health published a draft document, ‘On the approval of risk indicators <…> in the field of circulation of medical devices to be used as the basis for unscheduled inspections …’ (link in Russian).
The document sets out four indicators that may be used reasons for the regulator to initiate an unscheduled inspection/audit of medical device manufacturers and their representatives/distributors.

Suggested indicators include:

  • Discrepancies in information about medical devices published in the media with information submitted for registration.
  • Information revealed concerning a potential threat to human life or public health for a medical device registered in Russia that has been published by international regulatory agencies but not reported to the Russian competent authority.
  • Two or more warning notices regarding violation of the medical device regulations have not been replied by the manufacturer.
  • Information on a violation during pre-registration testing or clinical trials obtained by the regulator from monitoring the media.

To be recalled that risk indicators were introduced in November 2019 under the Russian medical device regulation, Resolution #1433 (link in Russian) and a previous version of the indicator list was published in January 2020.

According to Resolution #970 on the state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs regular planned and unplanned inspections of medical device manufacturers and their representatives.

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

Dear Colleagues,

Here is my monthly review of medical device regulatory changes in Russia and the Eurasian region:

 

  1. Temporary Simplified Medical Device Approval Process in Russia

On 6 April 2020, the Russian government released Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use in the prevention and treatment of coronavirus infection including lung ventilators, oxygenators, immunological and molecular assays for coronavirus (COVID-19), DNA/RNA sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothing. Resolution #430 introduced a simplified six-day batch-by-batch approval process valid until the end of 2020 that skips the current requirements for local testing for the medical devices and IVD products included in the list according to the 2n Regulation and allows for temporary batch approval for these products.

In late April 2020, two Russian expert centres published guidelines/recommendations on the new approval process detailed in Resolution #430 (link in Russian) including proposed programs for type-testing and clinical trials for molecular assays and immunoassays for diagnosing coronavirus infection.

On 16 April 2020, the Russian healthcare regulator Roszdravnadzor announced the first registration certificate issued for a batch of molecular assays for coronavirus (COVID-19) manufactured by the Russian manufacturer according to newly implemented process. At the end of April 2020, there are four approved medical devices in accordance with Resolution #430 in the official medical device register database.

At the same time, regulators warned of a potential violation of the law and emphasised that circulation of non-registered medical devices and using unregistered diagnostic tests and assays is prohibited.

 

  1. Updated Medical Device Examination Requirements in Kazakhstan

On 9 April 2020, the Ministry of Health of Kazakhstan published an updated version of Order #736 ‘On rules on expertise of medicines and medical devices’ (link for updated document in Russian) and enforced the following amendments for the medical device approval process in Kazakhstan:

  • Requirements have been significantly simplified for the required laboratory testing before the registration of medical devices: henceforward, the testing is not required for renewals of current registrations nor for the registrations of active (electric-driven) medical devices and medical devices approved in the European Union, USA or Japan;
  • A new accelerated registration path has been implemented for cases of emergency and for manufacturers with ISO 13485:2016 certification from European Notified Bodies that have agreements with the Kazakhstan Ministry of Health;
  • Requirements for onsite testing have been updated: onsite inspection is required for registration when samples require special conditions for transportation or require special testing methods. At the same time, based on data from the documents, local laboratories may confirm some characteristics without inspection;
  • The sequence of the steps for obtaining medical device registration expertise has been changed: henceforward, the steps are initial examination, specialised stage and laboratory testing. However, there are still three steps and overall timelines remain unchanged.

Later, on 21 April 2020 the Kazakhstan National Center of Expertise of Medicines and Medical Devices updated information on registration and re-registration fees according to the new approval procedure.

  1. Statistics on Medical Device Approval in Russia for 2019

On 21 April 2020, Russian healthcare regulator Roszdravnadzor published the annual report with statistics on medical device registration in Russia for the year 2019. According to the published document, in the last year, 1469 medical devices were approved (39% for Russian and 61% for international manufacturers). The number of registration rejections last year slightly decreased (by around 12%) compared to the year before.

The regulator also reports about 3329 inspections were conducted that revealed more than 4000 nonconformities and 47 medical devices were restricted from circulation in Russia based on post-market monitoring over the last year. One medical device had been approved according to the Eurasian registration procedure. There are no updates to this number as of the end of April 2020).

 

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I would like to thank LIMI Consulting who helped me with the information regarding updates to Kazakhstan regulations in this post. Let me also remind you that you can receive monthly Russian medical device regulation updates directly to your email via the ‘follow’ button on the toolbar of this blog.

Russia Introduced Temporary Simplified Batch Approval Process for Medical Devices for Emergency Use

On 6 April 2020, the Russian government released the Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use for prevention and treatment of coronavirus infection (including lung ventilators, oxygenators, SARS immunological and molecular assays,  sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothes).

-The Resolution #430 introduced simplified six days batch-by-batch approval process for medical devices and IVD products included in the list until the end of 2020; The new approval process will skip he current requirements for local testing according to 2n Regulation;

– Resolution #430 allows importation of non-registered medical devices and IVD products included in the list for the type testing and clinical trials without additional permits;

– Resolution #430 allows delivery/selling in Russia of non-registered single use medical devices included in the list upon condition of their disposal after 1 January 2021.

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

Dear Colleagues,

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

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

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

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

 

Dear colleagues,

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

  1. Updated Criteria for Software as Medical Devices in Russia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dear Colleagues,

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

In addition to the significant and long-awaited milestone announcement made in early January 2020 on the first medical device approved under the Eurasian medical device regulations, over the last month, there were further updates in local regulation systems, which are discussed below:

1. Criteria for Unplanned Inspections by Russian Competent Authorities

In continuation development of regulations on medical device control procedures in Russia and following the resolution #1433 (link in Russian) enforced in November 2019, on 17 January 2020, the Russian Ministry of Health published the draft regulation ‘on approval of risk indicators of violation of mandatory requirements used as the basis for unscheduled inspections <…> for circulation of medical devices’ (link to the draft in Russian).

The published document provides ten criteria that may be considered by the regulator to be the reasons for initiating unplanned inspections of manufacturers of medical devices and other organisations involved in medical device turnover. Most of the criteria are centred on situations where the regulator receives information regarding certain issues such as violations of current regulation (i.e. about the circulation of falsified, poor quality, or unregistered medical devices), safety concerns with respect to a medical device discovered in the international databases that was not reported in adherence to the Russian regulation, off-label use of a medical device, and such other violations.
According to the information in the regulation database, the draft is currently open for public discussion until 06 February 2020.

However, let me remind you that according to Resolution #970 on state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs planned and unplanned inspections of medical device manufacturers. The list of organisations for planned inspections in 2020 was published by Roszdravnadzor at the beginning of 2020.

2. New Process for Importation of Samples for Registration in Russia

On 28 January 2020, the Russian Ministry of Health published a draft regulation (link in Russian) on the amendment of the procedure for importing samples of medical devices to Russia for registration and registration renewals. It should be noted that this process is currently regulated by the Order #7N.

According to the published document, samples for registration may be imported into Russia according to the special procedure single-use importation permit by the manufacturer of the product, or its authorised representative, registered in Russia as a legal entity. The number of samples allowed for importation is calculated by employing recommendations from laboratories conducting pre-registration testing. The sample importation permit is granted by the competent authority based on the application within five business days. According to the draft, this regulation is not applicable to software.
The draft is currently open for public discussion until 17 February 2020.

3. Belarus is Discussing Amendments in Price Regulations for Medical Devices

At the beginning of January 2020, the Belorussian Ministry of Antimonopoly Regulation and Trade published a draft order ‘on prices of medicines, medical devices, and its spare parts’. According to the published document, the Belarusian government is implementing the price regulation for certain groups of medical devices and their spare parts, which are included in the special lists approved by the Ministry of Health of Belarus. The document also established the trade margins, from 10 per cent to 40 per cent, depending on manufacturers’ selling prices or estimated prices.

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Thank you for following my blog intended to provide up-to-date information on medical device regulations in the region. Your feedback, questions, and comments regarding my updates are always welcome.