News Digest 04.08.2023 - 07.08.2023
Regulators
Medical image recorders are included in the list of medical devices for simplified registration
The Interdepartmental Commission has once again updated the list of medical devices for simplified registration in accordance with Decree of the Government of the Russian Federation No. 552 dated April 1, 2022. The list, which now has 1,930 items, includes dental medical devices, consumables, reagents, and medical image recorders.
Under a simplified procedure, it is now allowed to register surgical forceps for manipulating soft tissues, a tool for introducing and compacting dental materials, a hook for removing dental plaque, an endodontic plugger, a dental probe, and a reservoir for an insulin infusion pump.
Also on the list were hand-held scalpel blades, a cytological ecclesiastical brush, Clostridium difficile antigen kits for in vitro diagnostics, and medical video recorders.
Source: https://roszdravnadzor.gov.ru/documents/81664
The Ministry of Finance of Russia issued a letter regarding the procedure for applying VAT exemptions under Decree No. 1042, the sale and leasing (with the right to purchase) of a medical device that has a registration certificate with the code indicated in the list is not subject to VAT.
On the basis of the fourth paragraph of subparagraph 1 of paragraph 2 of Article 149 of the Tax Code of the Russian Federation (hereinafter referred to as the Code), the sale of medical goods of domestic and foreign production in the territory of the Russian Federation according to the list approved by the Government of the Russian Federation is not subject to taxation (exempted from taxation) by value added tax.
Source: https://base.garant.ru/407444845/
Market news
Mishustin instructed to submit proposals for the development of the production of domestic prostheses
Prime Minister Mikhail Mishustin instructed to submit proposals to the government on the development of the production of domestic raw materials, materials and components for the manufacture of prosthetic and orthopedic products intended for rehabilitation. He gave such an instruction following a meeting in July with members of the Federation Council to the Ministry of Industry and Trade, the Ministry of Labor, the Ministry of Health and Roszdravnadzor. According to the press service of the government, the relevant departments and the supervisory authority must submit their proposals by November 2023.
Medical device safety monitoring news
In the course of monitoring foreign regulatory authorities, the specialists of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor identified the following NS.
NIDEK is voluntarily recalling certain batches of EyeCee ONE preloaded and EyeCee ONE crystal preloaded intraocular lenses due to increased intraocular pressure in patients who have received these IOLs.
The Cook Company manufactured and distributed substandard stone and foreign body extraction baskets. The defective item has been discontinued.
MHRA - Executive agency of the United Kingdom Department of Health and Human Services responsible for the safety of medical devices and medicines.
Health Canada - Canadian government department responsible for national health policy.
In the course of MI monitoring on the territory of the Russian Federation, specialists of the Federal State Budgetary Institution “VNIIIMT” of Roszdravnadzor prepared for further investigation by Roszdravnadzor.
The automated information system of Roszdravnadzor received a message from a medical institution about a fatal outcome during the study when using the MRI machine. Due to insufficient information to determine if there is a causal relationship between the use of a medical device and an adverse event, a report from the manufacturer's internal investigation is pending.
Abbott Laboratories LLC submitted an adverse event report related to a system controller display error. There were no side effects or effects on the patient. The system controller has been replaced and new software has been installed with no interruptions to the product. Due to sufficient actions by the manufacturer, this case was closed.
Source: https://t.me/vniiimt/261
Other
Murashko spoke about the “wow effect” of Russian technologies in medicine
“Today, holding international forums to attract our colleagues and get acquainted with our technologies, we see the so-called wow effect,” Murashko said at the All-Russian meeting on topical issues of developing the primary health care system.
He noted that at the Russia-Africa forum, colleagues saw how technologies are developing in Russia, and this had a powerful effect.
“As a rule, doctors in those countries tried to focus on Western technologies, but, seeing the availability, including price, technological, of course, they turn towards manufacturers from Russia,” the minister emphasized.
Source: https://news.mail.ru/society/57313547/?frommail=1utm_partner_id=441
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