Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical device
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The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “On Approval of the Rulesr State Registration of Medical Devices”
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Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with
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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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On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the Circulation of Medicinal Drugs and Medical Devices – FarmMedObrashchenie – 2018” (hereinafter FMO-2018), a Laboratory Services and Confidentiality Agreement was signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor in the presence of Mr. Mikhail Murashko, the Head of
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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
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