According to the current legislation wholesale of medical equipment imported or purchased on the territory of the Russian Federation does not constitute a medical or pharmaceutical activity and therefore is not subject to licensing. The public services administrative procedure on state registration of medical products of Federal Service for Supervision in the Sphere of Health Care (approved by the order of Ministry of Health of the Russian Federation dated October 14, 2013 No. 737n) establishes the registration procedure for medical products. This registration is performed by the Federal Service for Supervision in the Sphere of Health Care in order to authorize medical products for production, import, sales and application on the territory of the Russian Federation.
All medical products intended for medical application on the territory of the Russian Federation are subject to registration. The document confirming registration of a medical product is the Marketing Authorization. A marketing authorization is valid on condition that all information specified therein remains unchanged, namely, information on the medical product and the name of entity which the medical product is registered for. Marketing authorization validity period is not limited.
The Regulation of the Government of the Russian Federation dated December 1, 2009 No. 982 (rev. dated September 26, 2016) specifies the unified list of products subject to mandatory certification and the unified list of products whose compliance is confirmed by adopting a declaration of conformity. According to the above-mentioned list certain medical products are subject to mandatory certification and declaration of conformity.
Our specialists will arrange delivery of any equipment you require from any manufacturing company by all modes of transport and from any point on the globe. We will strictly meet the agreed reasonable deadlines, ensure professional and timely completion of all customs clearance procedures, ensure that a declaration of conformity or, if required, a certificate of conformity, are available, and provide you with a complete package of all relevant documentation.
