News digest 04.07.2023-05.07.2023
Regulators
Approves the procedure for issuing permits for exporting medical equipment from Russia
According to the approved Order, in order to export medical equipment, an applicant must submit an application to Roszdravnadzor in paper form or via the agency's AIS, specifying information about the applicant, the model and characteristics of the medical device, and data from the registration dossier. The application must be accompanied by data on the recipient, the purpose of export, transit countries and the contract for the supply of medical equipment.
The package of documents will include information confirming the absence of a critical defect of medical goods on the territory of Russia. The regulator will have five working days to review the documents, and if there is a suspicion of a critical defect in the goods, it may extend the application for up to 15 days.
Roszdravnadzor will issue an export permit separately for each batch in a single contract. The regulation will be in effect until December 31, 2023.
Source: http://publication.pravo.gov.ru/document/0001202306300018
Roszdravnadzor responds to numerous reports about the poor quality of Chinese hearing implants for children
"In connection with the videos circulating in social networks about allegedly low-quality Chinese hearing implants for children, Roszdravnadzor informs as follows.
Medical devices "Enduro cochlear implantation system with accessories" and "Enduro speech processor for cochlear implantation systems with accessories" manufactured by the Chinese company "Zhejiang Nurotron Biotechnology Co., Ltd." are duly registered and authorized for circulation in the territory of the Russian Federation. Safety and efficacy of the implants have been confirmed in the process of testing.
During the entire period of their use, Roszdravnadzor has not received any reports of adverse events related to the use of these medical devices either from patients or medical organizations.
In connection with the above, Roszdravnadzor currently sees no obstacles to the circulation of these medical devices in the Russian Federation," Roszdravnadzor's Telegram channel reports
Source: https://t.me/roszdravnadzor_official/1567
Market News
FGBU "National Institute of Quality" Roszdravnadzor prepared an analytical review of the medical devices market for 2020-2022 years
According to the results of the analysis of the medical devices market in the Russian Federation for the period from 2020 to 2022, the following indicators have been analyzed:
- Volume of the medical devices market and dynamics of its development in value and quantitative terms.
- Share of domestic manufacturer presence and dynamics of its change in value and quantitative terms.
- Indicators of medical devices categories and their dynamics in value and quantitative terms.
- Dynamics of change in the number of suppliers and customers for the analyzed period at the federal and regional levels.
Detailed analysis is available at the link: https://marketanalyse.creatium.site/
In SEZ "Technopolis Moscow" began to produce ultrasound machines
NPO Scanner has launched production of ultrasound diagnostic devices under the brand name RuScan at the Pechatniki site of the special economic zone Technopolis Moscow.
Vladimir Efimov, deputy mayor of Moscow for economic policy and property and land relations, said: "The total area of the facility exceeds 600 square meters. About 40 workplaces have been created. After reaching the design capacity the company will be able to produce up to two thousand scanners per year, covering the main needs of the Russian market in this equipment. Investments in the project realization amount to 70 million rubles".
Source: https://www.mos.ru/news/item/125959073/
"Invitro" for 1.3 billion rubles launched a laboratory complex in Moscow
On July 5, Invitro Holding opened a flagship laboratory complex in the North-East of Moscow. KDL, previously located on Nagatinskaya Street, moved there. The area of the new complex is more than 8 thousand square meters (the previous one was more than 4 thousand square meters), more than 1.3 billion rubles were invested in the launch of the facility. The complex is designed to conduct 170 million studies per year.
Other
The government is asked to solve the issue of providing disabled people with rehabilitation equipment
The Federation Council has asked the government to solve the issue of providing disabled people with rehabilitation equipment. The upper house of parliament believes that the country cannot depend on supplies from other countries.
"We cannot depend on unreliable supplies from unfriendly countries. At the same time, our enterprises have all the necessary developments to replace foreign products, but it is very difficult to scale them without serious government support. In addition, special attention should be paid to the development in our country of the production of materials necessary for the manufacture of prostheses", - said V. I. Matvienko.
Novosibirsk scientists have developed a durable prosthesis to treat children with heart defects
Specialists of the Novosibirsk Medical Center named after Acad. E.N. Meshalkin together with scientists from Novosibirsk Akademgorodok have developed a pulmonary artery valve conduit for the treatment of children with congenital heart disease, which does not accumulate calcium and does not require frequent operations for replacement. The medical device is undergoing preclinical studies, Interfax reports citing Natalia Nichai, a researcher at the center.
Samsung Biologics has struck two deals with Pfizer worth $897 million
The South Korean company announced two agreements: a $704 million contract and an additional $193 million order that follows up on a deal announced in March to manufacture products for the US pharmaceutical giant.
Under the terms of the latest deals, Samsung Group's biotech division will produce biosimilars ranging from oncology and inflammation to immunotherapy at its new No. 4 plant in South Korea by 2029. Samsung Biologics said Pfizer's total orders this year reached $1.1 billion.
Earlier this year, the biotech division of the South Korean consumer electronics maker signed agreements with Eli Lilly, Novartis and GSK. In March, Samsung Biologics announced a plan to invest $1.54 billion by September 2025 to build a new pharmaceutical plant in South Korea.
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