News

The Government of the Russian Federation approved amendments to the supervision of the circulation of medicines and medical devices, as well as to control the quality and safety of medical care
The Chairman of the Government of the Russian Federation Dmitry Medvedev signed Decree of the Government of the Russian Federation No. 1433 dated November 9, 2019, which approved amendments to the provisions on state supervision of the circulation of medical devices and medicines, as well as on quality control and safety of medical activities. According ... More
14.11.2019
Introduction of changes to the documents contained in the registration dossier
We are pleased to present you an article about changes to the documents contained in the registration dossier. INTRODUCTION OF CHANGES TO THE DOCUMENTS CONTAINED IN THE REGISTRATION DOSSIER ... More
08.11.2019
Authorized Representative in Russia
Due  to  the  frequent  requests  of medical device`s Manufacturers to provide their interests as an Authorized Representative in Russia, we inform you that we are ready to provide all assistance in this matter both during the registration process of a medical device, and upon completion of this process. We will be glad to answer any ... More
07.11.2019
From October 28 to October 30, the annual Summit of the International Coalition of Drug Regulators (#ICMRA) takes place in Rome, in which a delegation of the Russian Healthcare Supervision takes part
These days, from October 28 to 30, the annual Summit of the International Coalition of Drug Regulators (#ICMRA) is taking place in Rome, in which a delegation of the Russian Healthcare Supervision Committee, headed by the head of the Russian Healthcare Supervision M.A. Murashko, takes part. A three-day meeting of regulators is held to exchange ... More
30.10.2019
Circulation of medical items in Russia
We are pleased to present you an article about circulation of medical items in Russia. This article combines the most frequently asked questions from Manufacturers of medical devices, clarifies some features of paperwork and is a kind of road map for the Manufacturer of a medical device to enter the Russian market. Circulation of medical ... More
23.10.2019
Result of our work
This week was successful, we received 5 Registration Certificates and replenished with new products ophthalmology, ultrasound diagnostics and cardiology. This time these medical devices are made in Japan, China, Korea and Poland. ... More
23.10.2019
FBSI of Roszdravnadzor IMTSEUAOSMP signed a Memorandum of Understanding with the Official Network of European Union Control Laboratories for the serial production of vaccines for human use and medicines from human blood and plasma (OCABR)
FBSI of Roszdravnadzor IMTSEUAOSMP signed a Memorandum of Understanding with the Official Network of European Union Control Laboratories for the serial production of vaccines for human use and medicines from human blood and plasma (OCABR) On September 30, 2019, a Memorandum of Understanding was signed between the Federal State Institution “Information and Methodological Center for ... More
11.10.2019
Our services
The main purpose of the work is solving problems for the purpose of medical products legal circulation in Russia and EAEU. When providing services, we fill out all forms for You, finalize the documentation for the requirements of the legislation, adjust (if necessary) the technical and operational documentation on the results of testing of medical ... More
03.10.2019
Statistics for registration of medical devices
We provide statistics for registration of medical devices for the current year. Registered medical devices – 946. Permits for clinical trials of medical devices were issued – 563. Permits for the import of medical devices with a view to their state registration – 2066. ... More
02.10.2019