The Federal Service for Surveillance in Healthcare is planning to issue allowance for manufacturing of non-registered medical devices for in vitro diagnostic of rare illnesses manufactured directly by the medical clinics according to the accelerated procedure and with mandatory publishing of the allowance at the web-site.

Changes of the production allowance issuance order will affect the devices covered by the Resolution No.2026 dated 24.11.2021. All the corresponding correctives will be published in the state law database.

The terms of issuance of the allowance are planned to be reduced from 50 to 33 working days, and prolongation of already issued allowances will take only 14 days instead of 30. The clinics can also not to submit a documents register as a part of the electronic application letter.

The medical devices that received the corresponding license will be added to the uniform state register of allowances and information on any of these devices will be available as a datasheet with a link by QR code.

In November,2021, the Federal Service for Surveillance in Healthcare has also developed and accepted the general rules of use of the devices for in vitro diagnostic, including their production, storage, maintenance and disposal. According to these rules, the clinics should use the original documentation of the manufacturer to produce the device by themselves and to keep all the information on the item for at least 15 years.