First registration certificate under EAEU regulation was issued in the end of December 2019: registration certificate is in action inside Russia and Kyrgyzstan, for medical device made in Russia
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Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration uses fast track for 1 risk class devices Government could changes classification rules (4n code) – and in this case code will be changed automatically by informing holder Permission of samples import – as a
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The Regional Dental Health Centre of Vladimir Oblast fined 200,000 roubles for violations identified by the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) during an unscheduled inspection As per an individual request in regards to the quality of dental medical services provided on a paid basis, the territorial authority of the Federal Service for the
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As of December 12, 2017, resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327 shall enter legal force, in accordance with which the following changes will be enacted in relation to the Regulation on the licensing of medical practice (with the exception of the indicated business conducted by medical organizations and other organizations included within a
Read moreRoszdravnadzor: over the 9 months of 2017 the prices for Vital and Essential Drugs (VED) fell by 1.1%. Over the 9 months of the current year, the level of consumer prices for medicines of the outpatient segment that are on the list of vital and essential drugs (hereinafter referred to as VED) fell by 1.1%. At the same time, the
Read moreIn the course of the joint action involving the Central Administration on Economic Security and Combatting Corruption of the MIA of the Russian Federation, the Regional Administration on Economic Security and Combatting Corruption of the MIA of the Russian Federation in Saint Petersburg and Leningradskaya oblast, with the recruitment of Roszdravnadzor personnel, the reselling of expensive medicinal drugs Mabtera and
Read moreMikhail Murashko, Head of Roszdravnadzor, attended the 12th Summit of the Regulatory Agencies’ Heads and took part in the annual meeting of the International Coalition of Medicinal Regulatory Agencies (ICMRA). Mikhail Murashko, Head of Roszdravnadzor, attended the 12th Summit of the Regulatory Agencies’ Heads and took part in the annual meeting of the International Coalition of Medicinal Regulatory Agencies (ICMRA),
Read moreAs a result of media requests regarding the functioning of the information and analytical system (IAS), the Ministry of Health of the Russian Federation and Roszdravnadzor report the following: At the present time, as part of the improvements being made to the State Procurement System, the Ministry of Health of the Russian Federation together with interested federal authorities, has been
Read moreTime for renewal process was prolongated before 2021 year. See details by our link here.
Read moreThe Resolution of the Russian Government named “On performance of the experiment for labeling with control (identification) signs and monitoring of the turnover of certain types of medications destined for medical usage” was signed. On January 24, 2017, Chairman of the Government of the Russian Federation Dmitry Medvedev signed the Resolution of the Government of the Russian Federation No. 62
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