An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs
MD Regulation
ROSZDRAVNADZOR
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
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
FAQ about MD registration
The article “Labeling of devices. Introduction
1. Introduction The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually every other phase of
MEDICALDEVICES
Medical devices that include components of animal origin
An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs
Medical devices and telemedicine
After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative acts of the Russian Federation regarding the application
Special aspects of import of medical devices, which include precursors of narcotic substances
In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances,
Import of medical device samples for the registration on the territory of Russian Federation
Order № 633 “On the introduction of amendments to the Rules of state registration of medical devices” came into force in June 2018. This normative