Category Archives: medicaldevices

Telemedicine in Russia – review

Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of

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Pharmaceutical substances and excipients

There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors. (details by link) However, medical devices can contain not only pharmaceutical substances but excipients. According to Federal Law 61 “On circulation of Medicinal Products” excipients are substances of inorganic or organic origin used in the

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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

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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

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