IVD device registration in Russia is controlled by the of Ministry of Health (Roszdravnadzor, or RZN). Risk classification is indexed the same as for medical devices (1, 2a, 2b, and 3), however the classification criteria are different with a majority of IVD products belong to Class 2a and 2b.
All devices are subject to technical performance testing and clinical trial testing reports generated at local, RZN accredited clinical sites and testing laboratories under RusAccreditation control. All documentation must be in Russian.
Approximate timeline for IVD reagent (with control materials, calibrators, etc.) registration is 9 months from start to finish including local Technical File and IFU development to Russian standards; and technical, biocompatibility testing and clinical trials. Typical project fees including government and third-party fees are US$13,000.
IVD analyzers will typically require 12 months for registration an about US$18,000 (including Technical File and IFU development according to Russian standards; technical, biocompatibility testing and clinical trials).
The exact cost for registration will be depending on how many registration certificates will be required to cover all the devices of interest. In Russia, separate applications are required for analyzers and consumables, risk classification as well as the quantity of models (due to size of Technical File and IFU and testing volume).
Contact Asia Actual to see if we can help navigate the registration process for your medical device in Russia.