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 subordinate departments, namely in VNIIIMT and CMIKEE.
The Federal Service for Surveillance in HealthCare would like to draw the attention of applicants for the state marketing authorisation of medical devices to the fact that related consultancy services will be provided by the following expert bodies subordinate to the Federal Service for Surveillance in HealthCare: FGBU All-Russia Research, Design and Testing Institute for Medical Equipment, a division of the Federal Service for Surveillance in HealthCare (FGBU VNIIIMT of the Federal Service for Surveillance in HealthCare) and the FGBU Center for Monitoring, Economic and Clinical Consultation, a division of the Federal Service for Surveillance in HealthCare (FGBU CMIKEE of the Federal Service for Surveillance in HealthCare).
Consultations provided in those institutions are held in accordance with the provisions of Order of the Federal Service for Surveillance in HealthCare No. 6478 dated 19 July 2017 “On the procedure for the provision of consultancy services by the Federal State Budgetary Institution All-Russia Research, Design and Testing Institute for Medical Equipment, a division of the Federal Service for Surveillance in HealthCare, and the Federal State Budgetary Institution Center for Monitoring, Economic and Clinical Consultation, a division of the Federal Service for Surveillance in HealthCare, in the field of procedures related to state marketing authorisation of medical devices”.
For detailed information about the aforementioned consultations, please visit the web sites of FGBU VNIIIMT of the Federal Service for Surveillance in HealthCare www.vniiimt.org and FGBU CMIKEE of the Federal Service for Surveillance in HealthCare www.cmkee.ru.