Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our

Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below: No. Item National
Read more »On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552 dated 01.04.2022 has been published
Read more »National registration system for medical devices in Russia (general registration by Order 1416 from 27/12/2012) is prolongated until the end of 2022 as well as national systems of other Members
Read more »The main legislative act regulating the procedure for state registration of medical devices is Resolution No. 213 dated March 23, 2018 “Regulations on the procedure for state registration of medical
Read more »The market of medical devices is an actively developing part of the pharmaceutical sector of the Uzbek economy. Despite the fact that import still plays an important role and account
Read more »The common space of the European Union allows the member states to take a more comprehensive and global approach to solving many issues, including the problem of circulation of falsified
Read more »The circulation of counterfeit medical devices (MD) and other medical products* is a global problem that poses a risk to public health and can cause significant economic damage. In this
Read more »The system of national marketing authorization of medical devices in the Russian Federation uses the Nomenclature Classification of Medical Devices by Type (hereinafter referred to as “NCMD”). In the system
Read more »For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of Roszdravnadzor with the participation of
Read more »What kind of activities are the subject of State funding programs The State funding program is regulated by Rules for the Provision of funding from the federal budget for Russia-based
Read more »Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our
Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our
On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552
National registration system for medical devices in Russia (general registration by Order 1416 from 27/12/2012) is prolongated until the end of 2022 as well as
Point-of-care testing devices Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding technical article, however one can’t say
The main legislative act regulating the procedure for state registration of medical devices is Resolution No. 213 dated March 23, 2018 “Regulations on the procedure
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
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
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
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
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 –
Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration
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
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