Medical device product registration in Russia is controlled by the of Ministry of Health (Roszdravnadzor, or RZN). Medical device definition (including non-critical IVD, stand-alone software and aesthetics devices) and risk classification are closely aligned with IMDRF guidelines, but with Class I measuring and sterile considered Class II in Russia; consistent with a general trend to up-classify devices in Russia compared to Europe.
Uniquely, all devices (Class I through 3) are subject to technical testing, biocompatibility testing, and clinical trial testing reports generated at local, RZN accredited clinical sites and testing laboratories under RusAccreditation control. It is possible to meet clinical data requirements with a locally generated clinical evaluation report with the existence of a registered predicate in Russia. All documentation must be in Russian.
Approximate timeline for Class 1 device 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 for Class 1 registration average US$13,000.
Class 2a, 2b, and 3 devices 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).
Another important and unique issue to Russian regulations is product grouping. In general, the number of applications required to cover all the models of interest will be greater in Russia compared to most markets based on number of models, portability and risk classification.
Contact Asia Actual to see if we can help navigate the registration process for your medical device in Russia.