The common space of the European Union allows the member states to take a more comprehensive and global approach to solving many issues, including the problem of circulation of falsified medical devices. As a result of the implementation of the global approach, regulations are being created to strengthen international cooperation, including with countries outside the EU (for example, the ConventionRead more
Tag Archives: PMS
The circulation of counterfeit medical devices (MD) and other medical products* is a global problem that poses a risk to public health and can cause significant economic damage. In this regard, there was a need to develop a single document aimed at combating counterfeit medical products. This was the MEDICRIME Convention. The MEDICRIME Convention (Council of Europe Convention on theRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).
In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027. Before talking aboutRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 980n).
With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From January 1, 2021, two legislative acts (Order No. 980n from 15th Sept 2020 (monitoring system) and Order No. 1113n) come into force, which significantly details the procedure for interaction betweenRead more