Approved the procedure for the use of non-original components for medical devices
Roszdravnadzor approved the list of documents provided to confirm the safe use of components or accessories in conjunction with medical devices that are not provided for in their technical and operational documentation, developed in February this year.
Order No2983 dated May 16, 2023 sets out the requirements for the content of the documentation and includes a form of conclusion on the possibility (impossibility) of using non-original components or accessories. The order will be valid from 09/01/2023 to 01/01/2023.
To obtain a permit, you must:
submit an application, providing information about non-original components, including documentation on the risk analysis and tests carried out;
information about products with which sharing is possible;
information about original components.
Also attached to the package of documents: a manual for installation and dismantling, a passport or specification, photos of the product, a letter of guarantee confirming the possibility of testing, efficiency, performance characteristics and parameters of the medical device.
In addition, the order contains a list of information about non-original components or accessories of the medical device. Data about them are published on the official website of the FGBU VNIIIMT.
As a result of the sanctions imposed in 2022, a number of preventive measures were proposed by the executive authorities in order to reduce the risk of shortages of goods. At the beginning of this year, the use of non-original components with medical devices became possible, and in April a regime for their facilitated registrationwas introduced. The use of non-original parts will avoid downtime of medical equipment in Russia.