July 17, 2015 came into force an directive from the Ministry of Health of Russia dtd. 03.06.2015 № 303n “On Amendments to the Directive of the Ministry of Health of the Russian Federation of 21.12.2012 № 1353 n” On approval of the process and conduct of examination of quality, efficiency and safety of medical devices”, which is supposed to simplify the procedure of state registration of medical devices of potential risk class 1.
Registration of such products will be held in one step if the the package of documents submitted for registration will include the information confirming the clinical efficiency and safety of health products (including clinical data, the analysis of the scientific literature, and (or) unpublished data and notifications, correlated with the intended manufacturer of medical products using the registered and the proposed method of use).
Roszdravnadzor pays the attention of the applicants, that the procedure of simplification for the state registration of medical devices potential risk class 1 will apply only to those applications which will be submitted to the Federal Service for Supervision of Health after the entry into force of the above directive.
BAKIT informs you about further details and new regulations from Roszdravnadzor.
More on the official website of Roszdravnadzor