Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list
MD Regulation
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
FAQ about MD registration
About trials on the spot
Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot
MEDICALDEVICES
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
Technical regulation for photonics
Which problems photonics regulation has? By link – article from magazine about current situation in this area. Main players in medical device area from photonics