The EEC Council approved a transitional period for the treatment of medical devices according to national rules until 2026
The Council of the Eurasian Economic Commission (EEC) approved amendments to the “Agreement on uniform principles and rules for the circulation of medical products.” The changes relate to the transitional period and will come into force after the project is signed by representatives of all member countries of the Union. Amendments are supposed to be ... More
The SEZ “Technopolis “Moscow” for 170 million rubles will launch the production of drugs for mesotherapy and biorevitalization
Subsidiary of the group of companies “Mesopharm” – LLC “Mesoformula” – will invest 170 million rubles in the production of drugs for professional and medical cosmetology. The plant will be built on the site of the special economic zone (SEZ) Technopolis Moscow, and its launch is scheduled for the third quarter of 2022. “The plant ... More
The profile committee of the State Duma approved the expansion of the powers of Roszdravnadzor to confiscate medical products
The State Duma Committee on Health Protection at a meeting on March 24 recommended that the deputies adopt in the first reading a bill on amendments to 323-FZ “On the basics of protecting the health of citizens in the Russian Federation.” The proposed draft amendments regulate the right of Roszdravnadzor to make decisions on the ... More
Philips and Amiko signed an agreement on the production of MRI in the Moscow region
The Dutch manufacturer of medical equipment Philips and the Amiko group of companies signed an agreement to organize the production of magnetic resonance imaging (MRI) scanners on the basis of the JSC “Rentgenprom” plant in the Moscow region. The volume of investments in the project has not been disclosed, the planned capacity is up to ... More
Replacement of blanks of registration certificates
Dear colleagues! Recently, we are very often contacted with the question: what to do if they did not manage to change the RU form issued before the entry into force of Order 1416 (The replacement should have been carried out before January 1, 2021) According to the information we have, all RUs that have not ... More
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