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 HealthCare about the initiation of their operations.

On 26 May, 2018, an Order of the Government of the Russian Federation was issued (No. 603), amending the list of public services which may be provided by the federal authorities and by state non-budgetary foundations on the basis of a “single window” arrangement in the Multi-Functional Centers for the provision of public and municipal services (MFC).

According to this amendment, the Federal Service for Surveillance in HealthCare is now excluded from the list of federal agencies authorized to provide public services on accepting and registering notification about initiation of the operation of certain type (work and services) by the legal entities and individual entrepreneurs via MFC on the basis of a “single window” arrangement.

In accordance with the Rules for the provision of notification about the initiation of certain types of business activities and on the registration of those notifications, as approved by Order of the Government of the Russian Federation dated 16 July, 2009, No. 584, the legal entities and individual entrepreneurs intending to perform work or provide services in the field of medical device circulation (except for holding clinical trials of the said medical devices, their manufacturing, assembling, commissioning. application, operation, including maintenance and repairs) shall provide related notification to the Federal Service for Surveillance in HealthCare in the event of the initiation of business operations.

Please be informed that we have prepared an Agreement on the Termination of the Cooperation Agreement for all Multi-Functional Centers for the provision of public and municipal services in all regions and republics of the Russian Federation which previously had entered into the Cooperation Agreement with the Federal Service for Surveillance in HealthCare.

– Agreement on the Termination of the Cooperation Agreement with MFC – Draft version

Official link (in Russian only) – http://www.roszdravnadzor.ru/news/12997