Author Archives: beawire

Should we expect the introduction of mandatory labeling for biologically active supplements in the Russian Federation?

According to the Russian Government Decision No. 1556, from July 1, 2020 , all operations related to drug circulation will be controlled in the information monitoring system. The monitoring system is already working for drugs from the list of high-cost nosologies. In addition to drugs, certain categories of goods are already subject to digital monitoring: tobacco products, perfumes, some clothing

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Technical testing of medical devices for in vitro diagnostics

According to the Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices” the term “technical testing” is defined as the testing to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and

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Registration procedure for medical devices for in vitro diagnostics

A medical device for in vitro diagnostics is any medical device intended by the manufacturer to study samples of human biological material without contact with a patient in separate application or in combination with other medical devices, only for the purpose of obtaining regarding physiological or pathological condition, and (or) fetal development problems, and (or) monitoring therapeutic interventions, and (or)

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Urgent registration process for Covid-19 tests is approved by Government

  Order of Russian Government 430 from 03th of April 2020 was published yesterday (06th of April 2020), what is inside: list of products intended to be used in special conditions (emergency, martial law and so on). In this list – IVD test for COVID-19, thermometers, artificial ventilator apparatus; registration certificate is issued on the base on series/LOTs of medical

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About us

Company BW, LLC is consulting agency for medical device and IVD product registration. Every day we develop technical documentation, which is compliant to Russian regulations and requirements. Our team supports whole cycle of registration from translation to sample import and testing arrangements. For each registration process are involved up to 7 specialists, each of the specialist is in charge of

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Biomedical Cell Products (BMCP) and High-technology drugs (HTDs): What is the difference?

More than two years have passed since the coming into force of the Federal Law No. 180 “On biomedical cell products”, however, no production site has yet passed the licensing procedure and no drug did not set foot on the national registration trail. Meanwhile, the EAEU market is becoming increasingly accessible not only for medicines and medical devices, but also

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COVID-19. Are there any effective medicinal products?

Since December 2019, the world has been struggling with a new infectious disease COVID-19 (COrona VIrus Disease 2019). This disease is caused by a virus belonging to the Coronaviridae family. The family includes two subfamilies and five genera which bring together more than 10 species that cause lesions of respiratory organs, gastrointestinal tract, nervous system in humans and animals. On

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Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

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