On 7 March 2013, the Head of the Federal Service for Surveillance in Healthcare, commonly known as Roszdravnadzor, retired from her position. Mrs Elena Telnova is replaced by Mr. Milhail Murashko. Mr. Murashko previously has worked for the Ministry of Health of the Russian Federation. Roszdravnadzor is the Russian authority that is responsible for the registration and surveillance of medical devices.
The change of management of Roszdravnadzor follows the adoption on 27 December 2012 of Decree 1416 entitled “On approval of rules of state registration of medical devices.” Many medical device manufacturers in Russia and abroad have complained about the fact that the secondary legislative documents necessary to implement this Decree have not yet been published. This has made the approval of new medical device registration submissions impossible. It is expected that the management change will further delay the backlog in registrations.
How have the Russian registration rules been amended? What are the causes of the delays in the registration process? How will the management change in the Federal Service for Surveillance in Healthcare affect the registration of medical devices in Russia? We will address these questions and more during a free webinar on March 20. Spaces are limited.