News Digest 14.08.2023 - 16.08.2023
Regulators
The government has updated the rules for licensing the maintenance of medical devices
The Medical Device Maintenance Licensing Rules have been updated. In particular, Roszdravnadzor was given the opportunity to make changes to the register due to a change in the name of the work performed or the services provided without assessing the compliance of the company or individual entrepreneur with licensing requirements and submitting an application for changes.
According to the document, Roszdravnadzor will be able to make changes to the register due to a change in the name of the work performed or the services provided without assessing the compliance of the company or individual entrepreneur with licensing requirements and submitting an application for changes.
For manufacturers and their authorized representatives, the requirements for obtaining licenses have been simplified. If they carry out maintenance of their own products, they will not need to have the measuring instruments and equipment provided for certain categories of medical equipment.
To obtain a license to carry out maintenance activities, the applicant submits an application in electronic form based on data from the Unified Identification and Authentication System and the Unified Register of Licenses in the personal account on the public services portal. No other documents are required.
In the application, the applicant, in addition to the details of the applicant, provided for in Part 1 of Art. 13 of the Federal Law “On Licensing Certain Types of Activities”, also provides: details of documents confirming the ownership of buildings or premises where maintenance is planned, the availability of equipment and measuring instruments necessary for this, as well as data on documents on the education of employees. Eliminated the obligation to provide information on the implementation by the applicant or licensee of the quality management system GOST ISO 13485-2017. However, it will be necessary to confirm the presence of the QMS at the pre-licensing check of the assessment of the applicant's compliance with the licensing requirements.
Market news
The range of the Russian market of medical devices is narrowing due to the reduction in the activities of foreign manufacturers
The Kommersant Publishing House has published an article on the current situation on the Russian market of medical devices. Andrey Vilensky, Director General of MEDITEX, was one of the experts.
The number of registrations of medical devices in the first half of 2023 decreased by 16.5% year-on-year, to 1.13 thousand units, Kommersant calculated based on the register of Roszdravnadzor. This is the deepest drop in annual terms since the beginning of the COVID-19 pandemic, when the Russian government introduced simplified registration of medical devices, including for increasing the production of respirators and tests. In the first half of 2020, the number of registrations increased by 2.9 times year-on-year, to 1.53 thousand units, and in the same periods of 2021–2022, the figure decreased by 3.7–8.4%.
The results of the first half of 2023 were affected by a decrease in the activity of foreign suppliers, say consultants for bringing medical devices to the Russian market (Medrelis and MEDITEX companies). Many Western manufacturers stopped projects until better times or abandoned them altogether, said Yury Matviyenko, general director of Medrelis.
After the outbreak of hostilities in Ukraine, deliveries to the Russian Federation were stopped by the American manufacturer of respirators and dental products 3M, the supplier of laboratory, diagnostic equipment and reagents Thermo Fisher Scientific, the manufacturer of diagnostic equipment Agilent Technologies, the biotechnology company Illumina, etc.
The number of permits issued by Roszdravnadzor for conducting clinical trials of medical devices in the first half of 2023 decreased by nine times, to 70 units. According to the CEO of Medleveltech, Mikhail Vinogradov, this is due to the simplification in 2022 of the rules for registering medical devices recognized as defective. Now, for the market launch of most of the names, except for the classes of high-risk medical devices, implantable and not having registered analogues, a separate permit for clinical trials is not required, he points out. But, as Andrei Vilensky, the founder of the STC "MEDITEX", notes, it was not possible to stimulate manufacturers to more actively withdraw medical devices in this way.
Source: https://www.kommersant.ru/doc/6136838
FAS canceled the results of the Moscow offset for medical furniture for 5.1 billion rubles
The Commission of the Federal Antimonopoly Service (FAS) found violations in the offset contract for the localization of medical furniture in Moscow for a total of 5.1 billion rubles. According to the commission, the customer, represented by the Moscow Health Department (DZM), violated the Law on the contract system when generating the notice. The FAS ordered to return the applications submitted for the competition, bring the notice of the competition into the proper form and re-determine the winner. This is the second offset that causes complaints from regulators. Previously, antimonopoly officials considered it illegal to combine different types of medical devices in offset for the needs of the blood service, as a result of which the DZM was forced to cancel the tender.
The Ministry of Health will equip medical institutions with equipment for the treatment of diabetes
The Ministry of Health will establish rules for the provision and distribution of interbudgetary transfers for endocrinological centers and rural medical institutions. The allocated money will be used to equip them with medical equipment necessary for patients with diabetes.
The Ministry of Health will equip endocrinological centers and schools for patients with diabetes. The corresponding draft resolution is posted on the regulation.gov.ru portal. Changes are being made to the state program "Health Development".
The document establishes the rules for the provision and distribution of interbudgetary transfers from the federal budget to such institutions for equipping or re-equipping them with medical devices. In addition, the Ministry of Health will equip rural medical organizations (CRH, district and district hospitals) with equipment necessary for patients with diabetes.
Thus, the selection criterion for a Russian region to provide an interbudgetary transfer will be its inclusion in the federal project “Fight against Diabetes”. With equivalent technological characteristics of medical devices, preference will be given to Russian-made products. The amount of the interbudgetary transfer is not specified in the document.
Inpline will invest 112 million rubles in the production of vacuum test tubes in Perm
The Inpline company, which specializes in the manufacture of plastic containers, intends to organize the production of vacuum test tubes for blood sampling in the Perm Territory. The total budget of the project is 112 million rubles - the company will receive most of the funds as a soft loan from the federal and regional industrial development funds (IDF).
Other
The investment holding Exor, which is the largest shareholder of Ferrari and controls Juventus, has acquired a stake in Philips
Exor said that the holding is going to become a "long-term minority investor" in the company. He bought Philips shares on the market, so the shares of other shareholders will not be diluted, writes the Financial Times.
The deal comes amid Philips' efforts to shift away from electronics to medical technology. Previously, the company's plans were overshadowed by the recall of breathing apparatus, due to which Philips shares fell by 60% since April 2021, and the former head of the company resigned.
Exor is the largest shareholder of Stellantis, Ferrari and CNH Industrial with a capitalization of 19.5 billion euros. Historically, the holding has invested in the production of cars, so the deal indicates further diversification of the portfolio.
Source: https:/ ko.ru/news/kholding-sovladeltsev-yuventusa-i-ferrari-kupil-15-philips-/
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