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


Dear Colleagues, 

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

1. New Procedure for Importation of Samples of Medical Devices into Russia

On 30 September 2020, the Russian Ministry of Health published Regulation 661N (link in Russian) and updated the procedure for obtaining an importation permit and importing samples of medical devices for registration in Russia. 

The new regulation will go into effect in January 2021, and unlike the current procedure described in Regulation 7N, the entire new procedure will be completed only in electronic form.

The importation permit is required for bringing in samples of medical devices for preregistration testing. It will be required for any medical device made by a foreign manufacturer, except medical software. It will be issued free of charge by the regulator Roszdravnadzor within five business days and will be valid for one year.

The Regulation lists the documents required for obtaining an importation permit and the list of reasons for the rejection of a submission.

2. Updated Guidance on VAT Application for Medical Devices in Russia

On 19 October 2020, the Russian Ministry of Finance published letter N0307-07/90841 (link in Russian) and provided guidance on the application of value-added tax (VAT) exemption on the sale of medical devices and its components in Russia.

According to the document, exemption from VAT is applied on the conditions that there are registration certificates for the medical devices and that they are included in the list found in Resolution 1042.

If the components necessary for the intended use are sold together with medical devices and in the amount specified in the delivery set, then these components should be recognised as integral parts of medical devices and exempted from VAT.



3. Criteria for Humanitarian Use of Medical Products in Kazakhstan

On 14 October 2020, the government of Kazakhstan published Resolution 662 (link in Russian) and updated the list of cases when pharmaceutical products or medical devices are allowed to be imported into the country for humanitarian use.

The regulation allows importation – without the approval/registration by the Ministry of Health – of medical products for the prevention and elimination of the consequences of natural and civil emergencies, as well as during the start of a state of emergency; of medical products that are intended for prevention and treatment of especially dangerous infectious diseases; and of orphan (rare) diseases.

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, 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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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).

Russia and Kyrgyzstan approved the First Medical Device under the Eurasian Regulations

On 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced first medical device approved under the Eurasian medical device regulations  First registration certificate was issued for 2A class neonatal phototherapy lamp manufactured in Russia.  The registration record has also appeared in the Eurasian database. 

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

 

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.