Roszdravnadzor will be able to issue permits for the import of unregistered medical devices into the country for specific patients. The decision was made at a government meeting on October 14 and published today on the website of the Cabinet.
“The project provides for the vesting of Roszdravnadzor with the authority to issue, in accordance with the procedure established by Russian legislation, permits for the import of unregistered medical devices into the country for the provision of medical care according to the vital indications of a particular patient,” the decision says.
In addition, Roszdravnadzor will issue approvals for clinical trials of medical devices, as well as be responsible for organizing the assessment of an application for a test permit.
Roszdravnadzor will also monitor the safety, quality and efficiency of medical devices, suspend or prohibit the use of drugs that pose a danger to human life and health, as well as substandard, counterfeit or falsified medical devices.
The department will be able to withdraw them from circulation on the territory of Russia in accordance with the legislation of the Eurasian Economic Union, the text of the decision says.
In September, it was reported that the Ministry of Health had developed amendments to the legislation that would give Roszdravnadzor the authority to allow the import of vaccines and medicines not registered in Russia for clinics that are members of the Moscow International Medical Cluster. Thanks to this, Russians will be able to be vaccinated with foreign vaccines.
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