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
MD Regulation
FAQ about MD registration
How to find out if a medical device is registered or not?
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
MEDICALDEVICES
Marketing authorization of Medical Devices for aviation in Russia
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
Lasers used in cosmetology
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
In vitro diagnosis of autoimmune diseases
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).
Triclosan in the composition of medical products
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
ROSZDRAVNADZOR
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
Plastic surgery will have to comply with new requirements
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