With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety

Currently, many Russian people have deficiency in such biologically active substances as: polyunsaturated fatty acids, native (animal) proteins, vitamins (C, B1, B2, A, beta-carotene, E and others), mineral compounds (Ca,
Read more »In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small
Read more »With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From
Read more »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
Read more »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
Read more »During the COVID-19 pandemic, sectors of the economy such as education and health are particularly digitalized. Of course, it cannot be said that the current situation was a reason for
Read more »Veganism as a philosophy and cultural course is known, perhaps, to every modern person. Popularization of respect for various life principles, including veganism, can be traced in different spheres of
Read more »With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets,
Read more »Fast track registration – Order of Russian Government 430 (as well as 804) – is prolongated until 2022. Already issued registration certificates should be renewed.
Read more »Electromagnetic compatibility (EMC) is the modern concept that combines such popular electromagnetic phenomena as radio interference, effects on the network, overvoltage, voltage fluctuations in the network, electromagnetic influences, grounding effects,
Read more »With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety
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 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 control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the
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 –
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
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
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
In connection with the recent tragic events attributed to plastic surgery, the Ministry of Healthcare of the Russian Federation has amended the requirements for the
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
Marketing authorization of Medical Devices (MD) for aviation and the registration procedure for “conventional” medical devices are different. The main difference is the special aspects
The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost
Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG).
Not so long ago on our site there were published several articles devoted to the most sensational categories of substances, which are often included in