From March 1 next year, Roszdravnadzor is authorized to issue permits for import into the Russian Federation of unregistered medical devices that are intended for the provision of life-saving medical care for specific patients, the Ministry of Health reports. Previously, such a procedure was not regulated by any laws or legal instruments.
Other amendments will be also made to the regulation on Roszdravnadzor. They will define changes in the sphere of circulation of medical devices both at the national level and within the framework of the Eurasian Economic Union (EAEU).
“The amendments define the powers of Roszdravnadzor in terms of its licensing and control functions related to the circulation of medical products on the territory of the EAEU. Thus, the market of medical devices, following the market of medicines, actually begins its transition to functioning in accordance with supranational legislation,” said Mikhail Murashko, the Minister of Health.
The updated regulation covers the monitoring of the safety, the quality and effectiveness of medical devices. Roszdravnadzor is obliged to report to the EAEU information system on adverse events related to medical products.
In addition, the supervisory authority will have a right to take measures to suspend or prohibit the use of medical devices that create a risk for human life and health, or are substandard, counterfeit or falsified, as well as to withdraw them from circulation in the country in accordance with the legislation of the EAEU.