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19.08.2022 (Обновлено: 26.08.2022 10:19)

EAEU defined entities that can inspect organizations on medical device circulation

The Eurasian Economic Commission's Council has specified the circle of entities that can be inspecting organizations in the field of circulation of medical products.

In the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System of Medical Products, Depending on the Potential Risk of Their Use, approved by Decision No. 106 of the Eurasian Economic Commission's Council dated November 10, 2017, the definition of the concept of "inspecting organization" has been changed. Taking into account the change, the inspection of production will be carried out either by the authorized body of the EAEU country in the field of circulation of medical products, or by its subordinate organization.

"Inspection of the production of medical products is provided for by the system for regulating the circulation of medical products that operates in the EAEU," Viktor Nazarenko, EEC Minister in charge of Technical Regulation, said. "In addition, this procedure is an important stage in the admission of medical products to the Union market."

The change will increase mutual trust of the EAEU states in the results of inspection of the production of medical products and will positively affect the availability of medical products within the EAEU.