26 June 2019
The Ministry of Health of the Russian Federation responded to the collective appeal of distributors of medical devices f submitted in early May 2019, asking the regulator to clarify the meaning of the requirement of Roszdravnadzor to provide documents confirming the legitimacy of using a trademark when applying for medical device registration.
According to the ministry, Roszdravnadzor has the right to check the compliance of the trademark of the medical device with the original only in a form of «interdepartmental information interaction», and this possibility has not been established as a mandatory requirement.
As indicated in the response of the Ministry of Health, prepared by the Deputy Director of the Department of Drug Supply and Regulation of Medical Products Svetlana Semecheva, in accordance with the government decree No. 1416 Roszdravnadzor checks the completeness and accuracy of the information contained in the application for registration of medical devices.
In particular, it is noted in the response of the Ministry of Health to distributors, Roszdravnadzor has a right to compare the information provided by the developer, medical device manufacturer or an authorized representative of the manufacturer, in a form of «Interdepartmental information interaction» in order to prevent the circulation of counterfeit medical products.
At the beginning of May, 28 distributors of medical products initiated by Medrelis submitted a collective appeal to the Ministry of Health asking them to clarify the situation around the requirement of Roszdravnadzor to provide documents confirming the legitimacy of using the trademark when applying for medical device registration.