Features of toxicology tests of medical devices within the national legislation of the Russian Federation

Author(s):  
Иван Каргин ◽  
Ivan Kargin ◽  
Маргарита Новикова ◽  
Margarita Novikova ◽  
Ольга Тарасенко ◽  
...  

The procedure and the rules of toxicology testing of medical devices (MD) for the purpose of their registration in the framework of the national legislation of the Russian Federation are discussed.

2021 ◽  
pp. 19-21
Author(s):  
Н.Д. Эриашвили ◽  
Г.М. Сарбаев ◽  
В.И. Федулов

В представленной статье рассмотрены проблемы коллодирующих привязок в международном частном праве и особенности их правовой регламентации в законодательстве Российской Федерации. Автором проанализированы особенности нормативного закрепления данного типа привязок в системе международных договоров, а также механизм имплементации этих норм в национальном законодательстве различных государств. На основе сложившейся практики применения коллодирующих привязок национальными органами государственной власти обоснована необходимость учета публичных интересов государства в данных правоотношениях. The present article examines the problems of collodizing links in private international law and the peculiarities of their legal regulation in the legislation of the Russian Federation. The author analyzed the peculiarities of this type of binding in the system of international treaties, as well as the mechanism for implementing these norms in the national legislation of various states. On the basis of the established practice of applying collodial links by national authorities, the need to take into account the public interests of the State in these legal relations is justified.


2020 ◽  
Vol 66 (5) ◽  
pp. 10-10
Author(s):  
L.I. Dezhurny ◽  
◽  
A.Yu. Zakurdaeva ◽  

The article examines organizational and legal problems related to state registration, production, procurement and use of medical devices for first aid. The study significance is accounted for by the need to find solutions to problems related to equipping first aid activities with medical devices, which is becoming extremely important for the modern Russian society. Moreover, a comprehensive study of these issues has not been undertaken so far. The purpose of the study is to develop a set of proposals of an organizational and legal nature to improve quality of medical devices for first aid and equipping all potential participants of first aid delivery with such devices. To eliminate the problem of low equipment of potential participants of first aid delivery with the means of delivery, the composition of first-aid kits, packs, sets, and packages for all categories of participants have to be approval by the Ministry of Health of the Russian Federation. The authors also propose organizational and legal measures to improve interdepartmental and intradepartmental cooperation in this direction with the Russian Ministry of Health playing the coordinating role. The authors have also identified the need for improving the procedure for state registration of the production of first aid devices either though amending the Federal Law "On the Basics of Public Health Protection in the Russian Federation" regarding the provision that first-aid kits, packs, sets, and packages equipped with medical devices registered in the prescribed manner are not subject to state registration. As an alternative, the authors propose amendments and additions to the Rules of the state registration of medical devices, providing for a simplified state registration of first-aid kits, packs, sets, and packages. In addition, the authors name arguments in favor of improving the clinical trial procedure for first aid medical devices and propose changes to Article 38 of the Federal Law “On the Basics of Public Health Protection in the Russian Federation” in terms of eliminating the problems of legal techniques in the definition of the term “medical device” regarding first aid. Keywords: First aid; first aid kits; first aid equipment; medical devices.


2020 ◽  
pp. 111-122
Author(s):  
Yury Y. Korolev

    The article analyzes the results of the Doing Business international rating for 2020 for the Republic of Belarus and the Russian Federation. Based on the actual rating data for two countries, the author investigated the methodology of the Resolving insolvency indicator, which is one of ten equilibrium components of the final Doing Business indicator and assesses the level of development of national economic and legal institutions of insolvency (bankruptcy). Some factors determining the lag of the Republic of Belarus and the Russian Federation from other countries, primarily the countries of the former USSR, are identified. On the example of India, the results of reforming the national legislation on economic insolvency (bankruptcy) and the transition to effective rehabilitation procedures of the debtor are evaluated. It is concluded that it is possible to use approaches and methods of calculating the Resolving insolvency indicator to develop areas for reforming national economic and legal institutions of insolvency (bankruptcy).


2021 ◽  
Vol 12 (3) ◽  
Author(s):  
Elena Orlova ◽  
Ekaterina Zavyalova

In the current context national goals in the field of economy are associated with further strengthening the competitiveness of Russian products on world markets, supporting national producers, stimulating investment activity. One of the conditions for their implementation is the application of regulation of foreign trade activities through the granting of benefits. The purpose of this article is to analyze and systematize the existing customs privileges within the framework of supranational and national legislation. A competent and transparent organization of system customs benefits allows not only foreign trade participants to save financial resources, but also to increase the investment attractiveness of the state. In the process of studying the EAEU legislation for customs privileges, it was revealed that different types of benefits are established by various regulatory legal acts; there is no understandable and clearly built system. The existing customs privileges are systematized and the basic rules for their application are described in the article. The content of each type of customs benefits has been disclosed. The analysis of the customs benefits in the Russian Federation during various periods of integration was carried out. Keywords. Customs regulation, customs benefits, preferences, customs payments, tariff privileges.


2019 ◽  
Vol 13 (1) ◽  
pp. 59-63
Author(s):  
S. N. Kondratovskaya ◽  
◽  
E. V. Valkova ◽  

The article covers controversial issues of legal regulation of labor of persons sentenced to compulsory and corrective labor. On the basis of an analysis of the norms of national legislation a conclusion was made on the priority of the norms of the Penal Code of the Russian Federation over the norms of labor legislation in the regulation of labor of convicts.


2019 ◽  
Vol 2019 (3) ◽  
pp. 24-27
Author(s):  
Анфиса Миронова ◽  
Anfisa Mironova

This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.


Author(s):  
Дарья Николаевна Веселова

В статье рассматривается современная климатическая политика Российской Федерации по двум направлениям: смягчение антропогенного воздействия на климат и адаптация к изменениям климата. Проведен анализ национального законодательства по вопросам климатических изменений. The article examines the modern climate policy of the Russian Federation in two directions: a mitigation of anthropogenic impact on climate and an adaptation to climate change. The analysis of national legislation on climate change done.


Author(s):  
E. V. Kazantseva

The article analyzes the norms of international and national legislation regulating the procedure for re-stricting the right of a person (a citizen of the Russian Federation and a foreign citizen) to freedom of movement and the grounds for such restriction. It is concluded that the restriction of human rights to freedom of movement is a consequence of the protection of the highest human value «the right to protect human health». Based on the study of legal acts of constituent entities of the Russian Federation with different names, such as «the emergency», «On the restriction of the right to freedom of movement and the introduction of high alert» and so on, taken to prevent the spread of coronavirus infection (2019-nCoV), the author points out the shortcomings of the highest officials of subjects of the Russian Federation in the preparation and adoption of legal acts, which restricted the right of citizens to freedom of movement on the territory of the Russian Federation.


2021 ◽  
Vol 16 (12) ◽  
pp. 11-23
Author(s):  
I. A. Rakov

Rules on taxation of controlled foreign companies in developed and developing countries are characterized by an anti-evasive regulatory function, which is implemented by means of re-qualifying the profits of such companies. Such relations require coordination not only at the national but also at the international level (actions of the BEPS Plan, recommendations of the Organization for Economic Cooperation and Development). The Russian Federation and the Federative Republic of Brazil, being the BRICS member states, are actively improving their national legislation, while comparative legal studies on the topic of tax retraining of these jurisdictions at an integrated level have not yet been carried out. Using Russian and Brazil approaches as an example, the author explores the problems of improving tax re-characterisation mechanisms, taking into account the general standards of countering tax evasion and erosion of tax bases (BEPS Plan).


Author(s):  
V. A. Bugaev ◽  
A. V. Chaika

The article discusses the problems of the relationship between international law in general and, in particular, international humanitarian law and the criminal legislation of the Russian Federation in determining responsibility for international humanitarian crimes. The analysis of the emergence of international humanitarian law, its fundamental principles and their reflection in the law of Russia and the Russian Federation.


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