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
MD Regulation
FAQ about MD registration
Difference in classification rules between national system in Russia and EAEU regulation
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
MEDICALDEVICES
Practice for the Regulation of Wearable Devices in the Russian Federation
Are Wearable Devices Considered Medical Devices? According to the definition of the Federal Service for Surveillance in Healthcare: Medical devices are any instruments, apparatuses, devices,
Foreign Practise for the Regulation of Wearable Devices
USA In the USA, medical device regulators consider wearable devices to be low-risk devices and therefore do not label them. For example, the U.S. Food and
Wearable devices: conditional classification
How to understand that this is a wearable device? In the previous article we analysed in detail the foreign and domestic definitions of the concept
Wearable devices. What are these?
Introduction So-called wearable technologies are becoming increasingly popular. This concept, however, came to us from the West. Therefore, you can find some inconsistencies in Russia
ROSZDRAVNADZOR
First online factory audit under EAEU regulation
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
First registration certificate under EAC MED mark
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
The Federal Service for Surveillance in Healthcare stopped the implementation of unregistered medical devices, as well as the carrying out of illegal plastic surgeries, at the specialized exhibition of the beauty industry “INTERCHARM Professional” in Moscow
On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement
As a result of joint actions by the Federal Service for Supervision in Healthcare and law enforcement agencies in the Orenburg region, illegal activities to manufacture and market an unregistered medical device were stopped.
As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the
This Laboratory Services and Confidentiality Agreement is signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor
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 –
Professional postgraduate education training “Clinical Studies (Investigations) of Medical Devices”
FGBU CMIKEE of the Federal Service for Surveillance in HealthCare will hold professional postgraduate education training “Clinical Studies (Investigations) of Medical Devices”. The Federal Service
Medical device approvals consulting
The Federal Service for Surveillance in HealthCare reminds you that consultancy services for applicants regarding marketing authorisation of medical devices are held in two FBGU
The Federal Service for Surveillance in HealthCare ceases cooperation with MFC
Legal entities and/or private entrepreneurs intending to perform work (services) in the field of medical device circulation shall notify the Federal Service for Surveillance in