The Government of the Russian Federation has allowed to perform medical devices maintenance and repairs with the use of components that are not listed in the documents for the device. This is reported by FV with reference to the resolution on the issue (No. 2525 of December 29, 2022).
“Resolution No. 552 of April 1, 2022 has been amended. According to the adopted document, this is possible if the safety of joint use is confirmed by technical tests and, if applicable, by toxicological studies conducted by the Russian National Institute for Research, Development and Testing of Medical Equipment (VNIIIMT) of Roszdravnadzor, as well as by clinical trials,” the publication writes.
Roszdravnadzor will have to approve a list of documents required for trials. In addition, the registering authority will have to develop a form of conclusion on the possibility of using such components, and a list of information about components or accessories of medical devices that are not provided for in their technical and/or operational documentation. According to the document, the list itself will be posted on VNIIIMT’s official website.
The duration of the registration procedure for medical products in Russia was reduced to 5-22 working days, according to a decision taken in April 2022.