Additional Services

• obtaining a duplicate of the Registration Certificate;
• organizing and holding consultations with Roszdravnadzor on the issues of classifying products as medical, if possible, registration of several types of products in one Registration Certificate, and other issues related to registration;
• preparation of a list of products for registration from the manufacturer's portfolio;
• assistance with responding to requests and notifications from Roszdravnadzor related to state control*;
• consultation on the circulation of medical devices on the market, including post-sale monitoring, reporting of adverse events, etc.;
• correction of technical errors in the registration certificate, change of the OKPD2 code**, nomenclature code ;
• - preparation and submission of letters and requests to Roszdravnadzor on any issues of interest to you related to the registration and circulation of medical devices on the market of the Russian Federation and the EAEU.
• - подготовка и подача писем и запросов в Росздравнадзор по любым интересующим Вас вопросам, связанным с регистрацией и обращением медицинских изделий на рынке РФ и ЕАЭС.

*Roszdravnadzor is endowed with the function of monitoring the circulation of medical devices after their registration and carries out inspections of all subjects of circulation, selects samples of any medical devices, conducts tests and issues appropriate expert opinions. If the medical device has not passed the examination under state control, Roszdravnadzor notifies the authorized representative of the manufacturer about this and asks to eliminate inconsistencies, withdraw the product from the market, etc. If the authorized representative of the manufacturer does not eliminate these discrepancies, then Roszdravnadzor can apply various methods of influence up to until the suspension of the marketing authorization and criminal liability.

** Medical devices with certain OKPD 2 codes have 0% VAT