The Ministry of Health of the Russian Federation plans to amend the rules of state registration of medical devices to accelerate the market introduction of Russian-made goods. A draft resolution on the issue has been published on the portal of regulatory documents.
According to Katren Style, the amendments will allow domestic manufacturers to register products in one stage if they have passed technical and toxicological tests at the Russian National Institute for Research, Development and Testing of Medical Equipment of Roszdravnadzor and clinical trials in medical organizations that meet the applicable requirements of the Ministry.
In this case, when a company applies for registration, the procedure will consist only in the examination of the completeness of technical tests and their results. Currently, such rules may be applied only when registering medical devices with a low degree of potential risk, software, as well as medical devices for in vitro diagnostics.
Registration of Russian-made medical products will take from 32 to 112 working days. It depends on whether additional data on the results of the expert examination will be needed. Currently, the authorities have to register medical devices within a period from 50 to 180 working days.
As it became known earlier, Russia is going to hold an experiment on medical devices labeling.
