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The EEC Council approves the protocol on amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices
The Protocol on Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union, which provides for the expansion of the list of medical devices that are not subject to registration within the Union, was approved by the Council of the Eurasian Economic Commission.
"The protocol was developed based on the proposals of the countries of the Eurasian Economic Union, taking into account the practise of applying regulatory legal acts in this area," according to the message.
According to the document, all medical devices made by individual orders of patients exclusively for personal use are not subject to registration; medical devices imported for medical care based on the vital indications of a specific patient; manufactured for export; representing stowage, kits, kits, and first aid kits completed in accordance with the legislation of the Member state and intended for circulation on the territory of this state.
It was previously reported that the Eurasian Economic Commission's Council amended the Rules for the Registration and Examination of Medicines for Medical Use. Tissue engineering drugs are a new class of high-tech drugs that have been discovered.