Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices amended

At its July 8 meeting, the Council of the Eurasian Economic Commission approved amendments to the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices.


In particular, the procedures for registration are clarified as to when it is necessary to include a new type of medical device in the Global Nomenclature of Medical Devices and in the nomenclature of medical devices of the Eurasian Economic Union.

The list of documents for registration of medical devices with low potential risk and for in vitro diagnostics is adjusted.

The adopted amendments will make it possible to optimize the procedure for registering and examining medical devices established by the EAEU law.