It is expected that in the near future amendments will be introduced to the Technical Regulations on the Classification, Labelling and Packaging of Chemical Products (UA CLP) and the Technical Regulation on the Safety of Chemical Products (UA REACH). The draft Resolution of the Cabinet of Ministers of Ukraine has been submitted to the central […]
Use of electronic instructions for medical devices
This year, the 11th Ukrainian Forum of Medical Devices Market Operators provided manufacturers, suppliers, distributors, importers of medical devices with a platform to resolve all pressing issues, discussions, recommendations and share valuable business experience during martial law.
Cratia as the general sponsor of this event, and it’s managing partner Maxim Bagreev made a presentation “The transition from paper to electronic instructions for medical devices”, in which he spoke about the rules of use and restrictions for electronic instructions in the world and in the European Union, advantages and legal requirements in Ukraine, as well as about the implemented project https://e-ifu.com.ua, which allows manufacturers of medical devices to switch from paper to electronic instructions, and allow convenient access for users to electronic and paper instructions.
After the end of the report, a discussion took place with the participation of representatives of state, regulatory and supervising bodies on practical use of electronic and paper versions of instructions during martial law for various groups of medical devices.
Link to the text of the presentation in Ukrainian language (pdf).
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