Medical equipment production in Russia

• Medical Equipment (Russian Market)

MRI production in Russia

Main article: MRI production in Russia

Chronicle

2024

In Moscow, launched the production of electronics for resuscitation medical equipment

Medplant, a resident of the Technopolice Moscow special economic zone, has opened a modernized workshop for the production of electronic modules for medical devices. This became known in early January 2025. The capacity of the new production will be 20 thousand modules annually. Read more here.

Why Russian manufacturers of ultrasound equipment cannot get into the register of domestic radio electronics

Russian manufacturers of ultrasound equipment face difficulties when trying to get into the register of domestic radioelectronic products, which significantly limits their ability to participate in public procurement and tenders. This became known in July 2024.

Despite the growing confidence in domestic medical devices and favorable market conditions, manufacturers cannot fully take advantage of the current situation. According to Medvestnik, participation in public procurement and tenders requires the presence in the unified register of Russian electronic products, created by the Ministry of Industry and Trade by Decree of the Government of the Russian Federation No. 878 of July 10, 2019. This register provides significant advantages, but to be included in it, you must fulfill a number of requirements and score a certain number of points.

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Фото: Unsplash

The score-based scoring system applies to 20 types of electronic products, including ultrasound equipment. Each product category has a minimum number of points, which is planned to be gradually increased. In 2023, the minimum threshold for manufacturers of ultrasonic devices was 65 points, in 2024 - 75 points, and in 2025 this figure will grow to 80 points.

Points requirements include the presence of a legal entity in Russia that is not controlled by foreigners, the presence of its own patents and rights to technology, design and technical documentation for design and production, as well as the degree of localization of technological processes. The more requirements a company fulfills, the more points it can score.

The main problem is that Russian manufacturers of ultrasound equipment often do not use domestic components, since they are not produced in the country. This makes it impossible to provide the necessary documents and makes it difficult to collect enough points to be included in the register. Despite changes in the rules of the Ministry of Industry and Trade, which allow you to include in the register of the company without documentary confirmation of purchases of Russian components, the point system remained the same.^[1]

Russian Prime Minister Mikhail Mishustin allocated 1 billion rubles for the development of components for medical equipment

Russian Prime Minister Mikhail Mishustin signed a decree on the allocation of 1 billion rubles for the development of components for various industries, mainly for medical equipment. The document was published on the official website of the Government of the Russian Federation on July 11, 2024.

According to the order, the funds will be sent to the Ministry of Industry and Trade of Russia from the reserve fund of the Government. The financing is intended to provide a subsidy to the autonomous non-profit organization Agency for Technological Development to support projects for the development of design documentation for components.

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Фото: Duma.gov.ru

A significant part of the allocated funds will be directed to the development of components for medical equipment. In addition, projects in the field of oil and gas and energy industry, automobile, construction and road and agricultural engineering will receive support.

We hope that the decision made will strengthen the technological base of the domestic industry, will contribute to the sustainable supply of raw materials and components, including those that are necessary to ensure the safety of life and health of our citizens, "Mikhail Mishustin emphasized at a government meeting on July 11.

According to the document, it is expected that within four years after the completion of project work, Russian organizations producing components according to the developed documentation will receive revenues of at least 2 billion rubles.

The reverse engineering project support program, under which these funds are allocated, was launched in 2022. It provides for the provision of grants for the development of design documentation with compensation for up to 80% of costs. The maximum grant for one project is 100 million rubles, and the development period should not exceed 24 months.

The Ministry of Industry and Trade of Russia is instructed to monitor the targeted and effective use of the allocated funds. The report on the results should be submitted to the Government of the Russian Federation by February 1, 2025.^[2]

2023

Russia and India signed an agreement on the joint development of medical equipment

In October 2023, Russia and India entered into an agreement on the joint development of medical equipment. The corresponding memorandum of understanding (MoU) was signed by the Association of Indian Medical Device Enterprises (AiMeD) and the Center for the Development of Strategic Partnership of Russia and India (DRISP). Read more here.

Mishustin exempted manufacturers of medical equipment from licensing requirements for the maintenance of equipment

Prime Minister Mikhail Mishustin signed a decree that exempted manufacturers of medical equipment from licensing requirements for the maintenance of equipment. The corresponding document was published on the official portal of legal acts on August 15, 2023. Read more here.

2022: Russia launches production of Onyx radiation therapy complexes

September 29, 2022 it became known about the launch of the production of Russian radiation therapy complexes "Onyx."

Production facilities, their scientific and design support, as well as licensing and marketing support from Rusatom Healthcare, according to the company's representatives, are able to fill the shortage of linear accelerators in Russia and make high-tech oncological assistance more accessible to the population. Read more here.

2020

Roszdravnadzor has developed a procedure for monitoring the production and maintenance of medical equipment

In October 2020, Roszdravnadzor developed and presented a procedure for monitoring the production and maintenance of medical equipment. The document was called "Administrative Regulations for the Implementation of Licensing Control of Production and Maintenance Activities (except if maintenance is carried out to ensure the own needs of a legal entity or individual entrepreneur) of medical equipment."

This regulation establishes the timing and sequence of administrative procedures and the procedure for interaction between structural units of Roszdravnadzor, as well as the information necessary for state control.

Roszdravnadzor presented the procedure for monitoring the production and maintenance of medical equipment

The inspection period may not exceed 20 working days. For one small business entity, the total period for scheduled field inspections cannot exceed 50 hours for a small enterprise and 15 hours for a micro-enterprise per year.

The period for conducting each of the inspections in relation to the licensee, which carries out its activities in the territories of several constituent entities of the Russian Federation, is set separately for each branch, representative office, separate structural subdivision of the licensee, while the total period for conducting the inspection cannot exceed 60 working days. The licensee shall be notified of the unscheduled inspection at least 24 hours prior to the start of the inspection by any available means.

Licenses are still issued by Roszdravnadzor. The requirements for license applicants and licensees have been clarified. Obsolete standards are excluded. Previously issued licenses must be re-issued by December 31, 2023.

The resolution comes into force on January 1, 2021 and is valid until January 1, 2027.^[3]

Russian enterprises obliged to increase the production of medical equipment by 25 times

On April 10, 2020, it became known that Russian enterprises were obliged to increase the production of medical equipment by 25 times. TASS Information Agency of Russia It is reported with reference to the deputy. Minister of Industry and Trade of the Russian Federation Oleg Bocharov

Enterprises are increasing their production of medical equipment, as in the Great Patriotic War, eight times in April there is a plan, 25 times to increase production in May, and 30 times in June, - he said in his opening remarks at the scientific and technical council at the Ural Optical and Mechanical Plant.

It became known that Russian enterprises were obliged to increase the production of medical equipment by 25 times

Oleg Bocharov added that following the results of the council, an agreement will be signed on the creation of a consortium of developers and manufacturers of medical equipment. The task of the consortium is to create a line of domestic equipment in all critical areas on the basis of a single digital platform.

The production of ventilators in Russia should increase at least 8 times by the end of April. The head of the Ministry of Industry and Trade Denis Manturov called on Russian manufacturers of medical equipment "to reach a completely new level" and increase export supplies of high-tech equipment.

Russia is already considered a country one of the most affluent in the world in terms of the number of ventilators per capita, Manturov noted. But Russian manufacturers continue to increase production - earlier in the country 100 ventilators were produced per month, and in April the production of devices will grow 8 times, in May - up to 2500 units, in June - 3000 devices.

Oleg Bocharov, deputy head of the Ministry of Industry and Trade, is confident that the situation with the COVID-19 coronavirus could allow Russia to enter international markets.

We have everything in order to concentrate our capacities, potential - not only in the field of ventilators, but also other complex medical devices, - Bocharov emphasized.[4]

2019: Rosatom and Elekta agree to localize linear accelerator production in Russia

On November 8, 2019, Rosatom announced that Rusatom Healthcare JSC had agreed to strengthen cooperation with one of the leaders in the production of medical accelerator equipment - Elekta Ltd. Cooperation involves localizing the production of Elekta high-energy linear accelerators at the production site of one of the enterprises in the contour of ROSATOM State Corporation. Read more here.

2018: SmithHelskea to build a medical equipment plant in St. Petersburg

On April 3, 2018, SmithHelskea announced the start of design of an enterprise for the development and production of medical devices and medical equipment at the site of the Novoorlovskaya Special Economic Zone (St. Petersburg). The company plans to start directly to the construction of a factory of medical devices and equipment under its own brand at the beginning of 2019. It is planned to invest 915.4 million rubles in the project . Read more here.

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