News Digest 25.07.2023 - 28.07.2023
Regulators
The Federation Council supported the bill on the purchase of medicines and medical devices from a single supplier
The Committee of the Federation Council on Budget and Financial Markets supported the draft law on the possibility of purchasing medicines from a single supplier. This role can be played by a state unitary enterprise of a constituent entity of the Russian Federation or a joint-stock company, 100% of whose shares belong to the region.
It is planned that the bill will be extended to the purchase of medicines, medical devices, medical nutrition, consumables, disinfectants, as well as services for the storage and delivery of relevant goods, repair and maintenance of medical equipment. If approved, the novel will enter into force on July 1, 2024. However, the draft stipulates that the regions can use the mechanism before this date.
According to the explanatory note to the bill submitted to the State Duma in May 2022 by a group of deputies and senators, some regions, for example, Tatarstan, the Chuvash Republic, the Arkhangelsk, Nizhny Novgorod or Kaluga regions, enjoy the right to purchase works and services, including to provide their population with medicines and medical devices through subordinate or owned enterprises, which are determined by the sole supplier.
Source: https://sozd.duma.gov.ru/bill/119762-8
The government has expanded the list of medical devices implanted under compulsory health insurance
Prime Minister of the Russian Federation Mikhail Mishustin signed a decree increasing the list of medical devices implanted under the CHI program. The list was replenished with only one of the three medical devices recommended by the commission of the Ministry of Health for inclusion in 2023 - a prosthesis of the dura mater based on a biopolymer composite, the applicant of which was the "BV Company". Two other products of production of Medtronic did not get to the list, and the list now contains 376 positions.
The list includes item code 323330 - a prosthesis of the dura mater based on a biopolymer composite. According to Roszdravnadzor, about 10 types of specialized medical devices manufactured by German, Chinese and American companies are registered in Russia. The description fits the patch registered in 2020 for repairing a defect in the dura mater NeoDuraTM manufactured by the Chinese-German Medprin Biotech (Medprin Regenerative Medical Technologies) with production sites in Frankfurt am Main (Germany) and Guangzhou (PRC).
Market news
The program for the purchase of mobile medical complexes will be extended until 2025
The Ministry of Health of the Russian Federation will extend until 2025 the opportunity to equip rural settlements and small towns with automobile ambulances (with the exception of ambulances) and mobile medical complexes (PMCs) through a program to modernize the primary link. In total, in 2022-2023, 2.75 billion rubles were allocated for the purchase of PMK, however, in the current version of the state program, purchases are completed this year.
Other
A new generation of orthopedic helmets was launched at the Turner National Medical Research Center
The Turner National Research Center for Pediatric Traumatology and Orthopedics of the Ministry of Health of Russia organized its own production of a new generation of orthopedic helmets using 3D technology for the treatment of various skull deformities in children.
New registered medical devices
We publish a list of new medical devices registered from 25.07.2023 to 28.07.2023
https://asiamc.ru/uploads/blogs/2023-07-28/medregs_20230728.pdfNews
