State registration of medical devices (MD) is a compulsory procedure aimed at confirming the compliance of particular medical devices to safety requirements.
All medical devices to be distributed and used in Russia, of both domestic and foreign manufacture, are subject to registration.
Registration of medical devices is carried out as consistent with the Rules of state registration of medical devices (RF government regulations dated 17/10/2013 N 930; dated 17/07/2014 N 670)
We specialize in registering electric medical devices.
A package of documents including a technical file, protocols of technical (including electromagnetic compatibility) and toxicity tests; operation file, clinical trial protocols and other documents are submitted for state registration.
If a medical device has metrological functions, a protocol confirming metrological characteristics of the product must be provided (to be put on the Register as a medical measuring device)
These documents must contain all the necessary information and be properly drawn up.
The documentation provided is examined as consistent with the Procedure for assessing the compliance of medical devices by way of technical, toxicity and clinical tests for the purposes of state registration of medical devices (Order of the Ministry of Health of the Russian Federation dated 09/01/2014 N 2н)
Registration Certificate is an official document confirming state registration of medical devices, and, therefore, the right to carry out activities related to manufacture, distribution and importation of such medical devices on the entire territory of the Russian Federation.
All devices used by medical providers must have a relevant registration certificate.
In addition, a registration certificate by Roszdravnadzor for essential and vital medical devices entitles one to tax benefits, and in certain cases to complete exemption from taxes.
We will be happy to answer all your questions by phone 8 (499) 394-58-68. Call us!
Or fill in the application form online and we will contact you as soon as possible.