In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present
MD Regulation
ROSZDRAVNADZOR
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
Fines for online stores
Don’t be involved in trafficking of unregistered medicinal products
Fines for violations
The Regional Dental Health Centre of Vladimir Oblast fined 200,000 roubles for violations identified by the Federal Service for the Supervision of Public Health and
Attention, medical organizations and private entrepreneurs!
As of December 12, 2017, resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327 shall enter legal force, in accordance with
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