Category Archives: medicaldevices

Sirolimus and its analogues in the composition of intravascular stents

At the present time registration of medical devices containing pharmaceutical substances is the topic for discussion for many manufacturers, distributors and other participants of the medical device market (see the article About pharmaceutical agents in the composition of medical devices and registration difficulties). Difficulties in the registration connected with the changes of Russian regulation touched upon drug-eluting intravascular stents. Stents capable

Read more

About pharmaceutical agents in the composition of medical devices and registration difficulties

In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation Provided by the Manufacturer (Maker) of a Medical Device,” came into force. This document specifies the requirements to the technical and user documentation for medical devices including those which contain drugs. However the interpretation of these requirements by Roszdravnadzor

Read more