Third coronavirus vaccine registered in Russia
Federal Research Center for Research and Development of Immunobiological Preparations M.P. Chumakov, on February 20, 2021, he received a registration certificate from the Ministry of Health for the KoviVac vaccine, developed to prevent coronavirus infection COVID-19. In mid-March 2021, it is planned to put into circulation the first 120 thousand doses of the vaccine. CoviVac ... More
The government approved the expansion of the powers of Roszdravnadzor to confiscate medical devices
The Government of the Russian Federation approved amendments to 323-FZ „On the Fundamentals of Health Protection of Citizens in the Russian Federation“, which regulate the right of Roszdravnadzor to make decisions on the seizure of falsified, low-quality medical devices and their destruction, as well as to file claims for enforcement of such decisions. The profile ... More
From January 1, 2020, the legislation does not provide for the issuance of a license in a paper version
The Federal Service for Surveillance in Healthcare informs that on January 1, 2021, the Federal Law of December 27, 2019 No. 478-FZ „On Amendments to Certain Legislative Acts of the Russian Federation regarding the introduction of a register model for the provision of public services for licensing certain types of activity ”, according to which ... More
Decree of the Government of the Russian Federation of December 15, 2020 No. 3321-R approves a set of measures for the formation of a modern industry of industrial products of a rehabilitation orientation in 2020 – 2022. The list includes, inter alia, the following measures: Development of new national standards in the field of the ... More
From January 1, 2021, a new procedure for reporting adverse events when using medical devices will come into force
The Ministry of Health has defined the rules for presenting information about the adverse effects and complications that have arisen when using MI. We are talking about the identified side effects that are not indicated in the instructions for use, about adverse reactions during the operation of medical devices, the peculiarities of the interaction between ... More
The government has established a minimum mandatory share of purchases of Russian goods. The quota mechanism will also apply to medical equipment and medical goods. So, for example, the share of domestic wheelchairs from 2021 in public procurement should be at least 50%. “The quota mechanism will enhance the effect for the domestic industry from ... More
Mikhail Mishustin signed a decree on accelerated registration of digital platforms in healthcare
Registration of software and the latest technologies in the field of medicine will take place in a simplified manner. The decree on this was signed by the Prime Minister Mikhail Mishustin. We are talking about digital programs that are used to help doctors diagnose cancer, plan surgical techniques, monitor the health status of elderly patients ... More
Roszdravnadzor signed a Memorandum of Understanding with the Main State Administration for Control over Medical Products of the PRC
On November 25, 2020, during the 21st meeting of the Russian-Chinese Commission on Humanitarian Cooperation, held in the format of a video conference chaired by the Deputy Prime Minister of the State Council of the People’s Republic of China Sun Chunlan and Deputy Prime Minister of the Russian Federation Tatyana Golikova, the head of Roszdravnadzor ... More
Moscow manufacturers of medical devices increased production by 12.7%
For the first nine months of 2020, manufacturers of medical equipment and instruments located in Moscow shipped products worth 11.2 billion rubles, which is 12.7% more than in the previous year. In total, more than 20 large and medium-sized enterprises of this profile operate in Moscow, said Vladimir Efimov, Deputy Mayor of Moscow for Economic ... More
Putin announced the need to reduce the duration of testing for COVID-19
Russian President Vladimir Putin pointed out the need to reduce the waiting time for a test for coronavirus infection. According to him, the 48 hours allotted by the standards is too long. „This is the standard for testing no later than 48 hours, after all, this is also long,“ TASS quoted Putin as saying. The ... More