There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains normative values of ambient temperatures for different
MD Regulation
ROSZDRAVNADZOR
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
Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products
Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on
Roszdravnadzor revealed gross violation of legislation in the clinic where a young woman died during plastic breast surgery. The medical facility in question is closed down
After receiving information about the death of the woman after planned plastic breast surgery in the OOO Elit Clinic company facility, the local office of
Roszdravnadzor: the terms of marketing authorisation and safety tests for medical devices conform to general world practice
The state marketing authorisation of medical devices (medical device registration process) in the Russian Federation is carried out in accordance with the Rules of State
The Government has simplified the rules of State registration of medical devices
The Federal Service for Surveillance in Healthcare informs about the adoption of the decree of the Government of the Russian Federation dated 31.05.2018 № 633
CMIKEE seminar 17.04.2018 about EAC MED
Main information from yesterday seminar provided by FGBU CMIKEE about EAC MED mark
Russian manufacturer CEO received criminal term
Criminal term for manufacture and distribution of an unregistered medical device
The manufacturer was fined 500 thousand roubles for supplying unregistered medical oxygen to a medical institution in Rostov
During a scheduled inspection the Territorial Division of Roszdravnadzor for Rostov region revealed that for a year Kislorod LLC had been supplying medical oxygen not
FAQ about MD registration
MEDICALDEVICES
Telemedicine in Russia – review
Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients.
Pharmaceutical substances and excipients
There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors.
Injectable cosmetics
Traditionally injectable cosmetological procedures are divided into four main groups: Botulinum Toxin Therapy, Biorevitalization, Mesotherapy and injections of microimplants.
Modern wound dressing
According to statistics, 40% of patients of surgical departments in Russian hospitals are individuals with wounds. In this regard, wound dressings are one of the most important groups of medical devices, circulating on Russian market.