Sep 9, 2013
Medical device market regulators in Russia have begun developing guidelines for evaluating quality, safety and effectiveness of in vitro diagnostic (IVD) devices.
Roszdravnadzor officials have started consultations with industry and academic sources in order to draw up uniform standards for IVD product reviews.
Final guidelines will be posted online by Roszdravnadzor after final sign-off by the Russian Ministry of Health. No specific timelines are yet available.
This marks the second announcement in recent days regarding medical device and IVD regulatory changes planned or underway in the Russian market. Emergo Group will provide further details on regulatory developments in Russia as we learn them.
Russian medical device market regulator Roszdravnadzor has begun providing updates that suggest greater alignment and harmonization with other countries’ rules and requirements. So far no concrete proposals have emerged, however.
On 7 March 2013, the Head of the Federal Service for Surveillance in Healthcare, commonly known as Roszdravnadzor, retired from her position. Mrs Elena Telnova is replaced by Mr. Milhail Murashko. Mr. Murashko previously has worked for the Ministry of Health of the Russian Federation. Roszdravnadzor is the Russian authority that is responsible for the registration and surveillance of medical devices.