State registration of medical devices (MD) is a compulsory procedure aimed at confirming compliance of particular medical devices to safety requirements.
All medical devices to be distributed and used on the territory of the Russian Federation (RF), 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 N 930 and N 670 dated 17/10/2013 and 17/07/2014, respectively).
We specialize in registering electric medical devices.
A package of documents including the 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 device must be submitted (to be then put on the Register as a medical measuring device)
These documents must contain all the necessary information and be properly drawn up.
The submitted documentation is examined for compliance with the Procedure for Assessing Compliance of Medical Devices by way of technical, toxicity and clinical tests for the state registration of medical devices (Order N 2н of the Ministry of Health of the Russian Federation dated 09/01/2014).
Registration Certificate is an official document confirming the state registration of medical devices, and, therefore, confirming the right to perform the activities related to manufacture, distribution and import of such medical devices on the entire territory of the Russian Federation.
All devices used by medical providers are obliged to possess relevant registration certificates.
Additionally, the Registration Certificate by Roszdravnadzor for essential and vital medical devices entitles one to tax benefits, and, in specific cases, completely exempts from taxes.
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