Registration of medical devices in Russia

Main Article: Medical Devices Market in Russia

2023: Mishustin instructed to work out the regulation of registration of medical technologies to achieve the technological sovereignty of the Russian Federation

At the end of December 2023, Prime Minister Mikhail Mishustin instructed the Ministry of Health and the Ministry of Industry and Trade to work out the issue of accelerating the mechanism for registering drugs in Russia, as well as to update the "road maps" for localizing the production of drugs and medical devices.

The Prime Minister of the Russian Federation gave instructions following the results of the strategic session held on October 24, 2023, which was devoted to large projects of technological sovereignty, involving the development of production based on its own development lines.

Mikhail Mishustin instructed the Ministry of Health and the Ministry of Industry and Trade to work out the issue of accelerating the mechanism for registering drugs in Russia

According to the press service of the Cabinet of Ministers, a separate block of instructions based on the results of the stratsession is devoted to the implementation of megaprojects aimed at localizing the production of the most demanded and strategically important drugs and medical devices. Thus, Deputy Prime Minister Tatyana Golikova was instructed to organize work on a legislative initiative that will regulate the development and registration of medical technologies in Russia, and then ensure the introduction of the corresponding bill to the Government.

The Ministry of Health will have to ensure, as a priority, the inclusion in the state assignments of scientific research related to the development of original drugs and the most popular medical devices, as well as medical technologies for the diagnosis and treatment of various diseases. The term is until January 25, 2024.

In addition, the Ministry of Health and the Ministry of Industry and Trade, together with Roszdravnadzor and Rospotrebnadzor, were instructed to update information on the needs for drugs and medical devices in order to plan the process of their development and production. Mishustin also instructed to prepare proposals to improve the procedure for applying patent law mechanisms for the most popular and strategically important foreign drugs.^[1]

2022

Mishustin significantly accelerated the issuance of permits for the manufacture of medical devices for in vitro diagnostics

At the end of August 2022, Prime Minister Mikhail Mishustin signed a decree that amended the "Rules for the provision, reissue, confirmation and cancellation of permission to use medical devices that are designed to diagnose diseases by conducting research on samples of human biological material outside his body, manufactured in a medical organization and used in the medical organization that manufactured them."

In accordance with this document, the deadlines for issuing a permit for the use of unregistered medical devices for in vitro diagnostics manufactured in medical organizations are being reduced. Now the duration of the stages will be from one working day to 33 working days instead of 3-50 days. In addition, anyone on the Roszdravnadzor website will be able to obtain information about the permits issued.

Mikhail Mishustin

In an expedited manner, Roszdravnadzor must also renew previously issued permits. Repeated public services should not exceed 14 working days instead of 30, which were originally. By submitting electronic applications, hospitals will no longer have to attach an inventory of documents.

All issued permits will now have to be entered into a single register of permits, in which everyone can request an electronic extract for the medical products of interest. The statement should be formed on request automatically with a link in the form of a QR code to the corresponding electronic record of the medical device in the register.

The changes came into force on August 27, 2022. Amendments to the 323-FZ "On the Basics of Health Protection of Citizens in the Russian Federation," allowing the possibility of manufacturing, storing and using unregistered medical devices for in vitro diagnostics if the medical organization had a permit issued by Roszdravnadzor for the use of such a product, were adopted by the State Duma, the Federation Council and signed by President Vladimir Putin on April 30, 2021.

Decree of the Government of the Russian Federation of 26.08.2022 No. 1499 "On Amending the Rules for the Provision, Reissue, Confirmation and Cancellation of Permission for the Use of Medical Devices Intended for the Diagnosis of Diseases by Conducting Studies of Samples of Human Biological Material Outside Its Body, Manufactured in a Medical Organization and Applied in a Medical Organization that Manufactured Them"

Mishustin accelerated the registration of the replacement of raw materials and components in medical devices

In early April 2022, Prime Minister Mikhail Mishustin signed a decree "On approval of the peculiarities of circulation, including the peculiarities of state registration, of medical devices in the event of their defect or the risk of defect in connection with the introduction of restrictive measures of an economic nature against the Russian Federation."

This document simplifies the procedure for amending the current registration certificates for domestic medical devices in the event of replacement of raw materials, components, components and spare parts or accessories. According to the new regulations, the examination of quality, efficiency and safety will take place within five working days, and Roszdravnadzor will issue an opinion within seven working days.

Prime Minister Mikhail Mishustin accelerated the registration of the replacement of raw materials and components in medical devices

According to the decree signed by Mishustin, the applicant will have to submit a package of documents on the relevant changes to Roszdravnadzor no later than 30 days from the date of updates. Among the documents should be test results confirming that changes do not affect quality, efficacy and safety or, conversely, improves properties and characteristics when the functional purpose of the medical product is unchanged.

At the end of February 2022, Russian manufacturers of medical equipment, due to difficulties "in connection with the introduction of sanctions and the cessation of supplies of foreign raw materials," prepared an appeal to the Government of the Russian Federation, the Ministry of Health, the Ministry of Industry and Trade and the Ministry of Economic Development with a request to soften the procedure for making changes to the current registration certificates caused by the replacement of raw materials and components. As a solution, representatives of the medical industry proposed introducing a notification procedure for replacing raw materials when amending existing regional administrations.

Resolution of April 1, 2022 No. 552

The registration period for medical devices has been reduced by 10 times

In early April 2022, Russian Prime Minister Mikhail Mishustin signed a decree that simplified the registration of medical devices. The Russian government has taken this measure to avoid a shortage in the market.

According to the press service of the Cabinet, state registration is required for the withdrawal of medical devices - imported from abroad or produced in Russia - to the market. The simplified procedure will allow you to obtain all the documents necessary for this as soon as possible. So, for certain medical devices, the registration period will be reduced from 50 to 22 working days, for others - to 5 working days.

Mishustin reduced the time for registration of medical devices by 10 times

The list of medical devices that can be registered in a simplified manner will be determined by a special interdepartmental commission. It will be created in the near future. It will include representatives of the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Finance, the Ministry of Economic Development, the Federal Antimonopoly Service, the Federal Customs Service and the Federal Tax Service.

Measures to support the import of pharmaceutical products were included in the package of proposals developed by the government to support the economy amid sanctions. Among the measures considered by the authorities were also the facilitation of procurement procedures for medical devices and the extension of the import substitution program for demanded drugs. At the end of March 2022, the Ministry of Health announced that despite the sanctions, the situation on the drug market in Russia was stable. However, by the end of March, sales volumes in the shadow sector increased amid a shortage of more than 80% of drugs in pharmacies, Kommersant reports.

Western countries have imposed several packages of sanctions against Russia. To combat the potential deficit, Russia imposed a temporary ban on the export of medical devices produced in countries that joined the sanctions. The ban applies to medical devices that are in the warehouses of importers or at customs.^[2]

2021

Increase in fees for registration of medical devices

In early December 2021, the Federal Service for Supervision of Health Care (Roszdravnadzor) announced the upcoming increase in state went to register medical devices. From January 1, 2022, they will be:

Roszdravnadzor raised state duties for the registration of medical devices

• for issuing a marketing authorization for a medical device - 11 thousand rubles (previously - 7 thousand rubles);
• for conducting an examination of the quality, effectiveness and safety of a medical device during its state registration:

• class 1 - 72 thousand rubles instead of 45 thousand;
• class 2a - 104 thousand rubles instead of 65 thousand;
• class 2b - 136 thousand rubles instead of 85 thousand;
• class 3 - 184 thousand rubles instead of 115 thousand;

• for making amendments to the documents contained in the registration dossier of a medical device that do not require an examination of the quality, effectiveness and safety of a medical device - 2,500 rubles;

• for conducting an examination of the quality, effectiveness and safety of a medical device when amending the documents contained in the registration dossier of a medical device:^[3]

• class 1 - 32 thousand rubles;
• class 2a - 48 thousand rubles;
• class 2b - 64 thousand rubles;
• class 3 - 104 thousand rubles;

• for issuing a duplicate marketing authorization for a medical device - 2,500 rubles.
• For actions related to the registration of medical devices intended for circulation on the general market of medical devices within the framework of the Eurasian Economic Union:

• for issuing a registration certificate of a medical device - 11 thousand rubles;

• for the examination of the safety, quality and effectiveness of the medical device during its registration, as well as for the approval of the expert opinion on the assessment of the safety, effectiveness and quality of the medical device during its registration:

• class 1 - 72 thousand rubles;
• class 2a - 104 thousand rubles;
• class 2b - 136 thousand rubles;
• class 3 - 184 thousand rubles;

Ministry of Health simplifies state registration of Russian medical devices

In March 2021, the Ministry of Health of the Russian Federation presented new rules for the state registration of Russian medical devices. They will come into force on September 1 and will be valid until the end of 2026.

As Kommersant writes with reference to a document prepared on behalf of Deputy Prime Minister Tatyana Golikova, it simplifies the procedure for registering medical devices - it will consist of only one stage, but if several conditions are met.

Simplified registration will be possible if the applicant conducts toxicological and technical tests in. All-Russian Research and Testing Institute of Medical Engineering Roszdravnadzor

The Ministry of Health of the Russian Federation simplifies the state registration of Russian medical devices

In addition, such medical products at the preliminary stage should undergo clinical trials in one of the national medical research centers (the list of which was approved by the Ministry of Health).

For foreign products, the registration rules will remain the same, except that the new version for Roszdravnadzor provides for the ability to send two requests at each stage of the examination to provide additional information. This, according to the authors of the initiative, will minimize the likelihood of refusal to register.

The reduced rules of state registration are also planned to be introduced for the least dangerous medical devices of the 1st class, medical devices for in vitro diagnostics and software, including the use of artificial intelligence technologies.

From January 1, 2022, registration of medical products will be carried out only in accordance with international treaties and acts constituting the law of the Eurasian Economic Union, in particular with the Rules for registration and examination of the safety, quality and effectiveness of medical devices, approved by decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46.^[4]

2020

The rate of registration of medical products in Russia increased by 2 times

The rate of registration of medical products in Russia by the end of 2020 more than doubled. This was announced at the end of August 2021 by the deputy head of Roszdravnadzor Dmitry Pavlyukov.

According to him, in 2019, 1,469 medical devices were registered, in 2020 their number increased to 3,630, including 1,969 - Russian medical devices and 1,661 - foreign.

Pavlyukov also noted that in 2020, for the first time, more domestic medical devices were registered in Russia than foreign ones. The market for medical devices has grown over the period of the COVID-19 coronavirus pandemic by more than one and a half times, he added.

The rate of registration of medical products in Russia over the 2020 year increased by 2 times

In March 2020, in connection with the spread of COVID-19, the Government of the Russian Federation by Decree No. 299 introduced an accelerated registration procedure for products with a low degree of potential risk of their use - respirators, medical masks, insulating gowns and suits, as well as gloves and shoe covers.

In April 2020, ventilators, oxygenators, artificial circulation systems, thermometers, as well as various test systems for SARS-Cov-2, including diagnostic systems for antibodies to a new type of coronavirus, fell under a simplified registration procedure.

According to Roszdravnadzor, as of December 2020, 1,342 medical devices were registered using a simplified scheme alone. At the same time, the simplified registration procedure was extended until the end of 2021.^[5]

Artificial intelligence from a Skolkovo resident was first recognized as a medical device

On April 22, 2020, the Skolkovo Foundation announced that Roszdravnadzor had registered the Webiomed medical decision-making support system as a medical device. This is the first software product with artificial intelligence that has passed technical and clinical trials and received permission for use in Russian hospitals and clinics. The Webiomed system was developed by a resident of the Skolkovo Foundation by the K-Sky Group of Companies. Read more here.

2019: Roszdravnadzor held a meeting on the issue of registration of software as a medical device

On October 21, 2019 TAdviser , it became known that To Moscow Roszdravnadzor in held a meeting with representatives of development companies medical ON and digital market experts on the health care issue of software registration as. The medical devices meeting chaired by the head of the RZN Mikhail Murashko was attended by heads and specialists of the department, as well as the Federal State Budgetary Institution VNIIIMT, GBUZ, NPCC DIT SDM Moscow representatives of medical software development companies, the Skolkovo Foundation law firm and Pepeliaev Group other experts. The association "National Medical Knowledge Base "(NBMZ) was represented by Boris Boris Zingerman Pastukhov, and. Alexey Gaidukov Alexander Gusev

At the meeting, almost the entire range of ideas and proposals for reducing regulatory barriers and problems related to government control and regulation of the medical device market was voiced, which, according to the definition of Article 38 323-FZ includes special software. The poles between which the discussion developed were, on the one hand, the point of view that the software cannot and should not be registered as a medical device, and on the other hand, the position of maintaining the current status quo ("do not change anything"). The result of discussions on this topic, obviously, should be a compromise, balanced solution primarily based on the priority in protecting the interests and safety of patients. It is also important to harmonize Russian regulations with the IMDRF guidelines and practices adopted in leading countries in the field of digital medicine.

In this regard, the parties decided to create three working groups under the auspices of Roszdravnadzor, which from various parties will consider the existing problems and form their proposals for changing legislation on this issue. Representatives of the Association of Developers and Users of Artificial Intelligence Systems in Medicine "NBMZ" will take an active part in the activities of working groups.

2017: Proposal to simplify the procedure for registering medical devices

In August 2017, the first meeting of the working subgroup on the development of high-tech medical devices of the expert council on the development of biotechnology, pharmaceutical and medical industries under the State Duma Committee on Economic Policy, Industry, Innovative Development and Entrepreneurship was held. Experts proposed to simplify the rules for registering medical products.

The meeting participants came to the conclusion that the introduction in Russia of international practice on the declarative form of confirmation of the compliance of medical devices with the required parameters if it already has a registration certificate would help to eliminate a number of problems when registering high-tech medical devices.

Experts propose to simplify the procedure for registering medical devices

During the discussion of the issue, the participants of the working subgroup noted that they face the same problems in the registration and circulation of medical devices.

The development and modernization of medical devices is largely constrained by administrative barriers that were formed decades ago. One of the options for solving the problem may be the introduction of international practice in the Russian Federation on the declarative form of confirming the compliance of medical products with the required parameters if the medical product already has a registration certificate. This will allow, with certain efforts, to remove administrative barriers and contribute to more dynamic development of the industry, - said the head of the subgroup Andrei Novitsky, director of the department for promotion and sales of civilian products of JSC "Production Association" Ural Optical and Mechanical Plant named after E.S. Yalamova "

In addition, experts proposed to change the scheme for adopting test protocols for medical products by accredited organizations, since manufacturers of medical equipment periodically have problems with an incorrectly executed test protocol produced in accredited laboratories.

Questions from representatives of the professional community are also raised by the insufficient number of experts in the country who are able to understand the specifics of the entire range of medical equipment; a multi-month waiting period for a response when submitting documents for registration of a medical product; the need to maintain a staff of highly qualified technical staff who deal exclusively with registration issues of medical products; in some cases - incomparably high re-registration costs, which are most affected by small enterprises, which are forced to cease operations because of this.

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