Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration
MD Regulation
ROSZDRAVNADZOR
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
Roszdravnadzor’s involvement in launching a project to organise the quality control and safety of medical activities in the Republic of North Ossetia-Alania
A project to improve the quality of work of healthcare organisations has been launched in the Republic of North Ossetia-Alania.
About quality of cosmetological services (RZN announce)
About quality of cosmetological services
FAQ about MD registration
MEDICALDEVICES
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.
Sirolimus and its analogues in the composition of intravascular stents
At the present time registration of medical devices containing pharmaceutical substances is the topic for discussion for many manufacturers, distributors and other participants of the
About pharmaceutical agents in the composition of medical devices and registration difficulties
In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation Provided by the Manufacturer