Medical device registration certificate
In the Russian Federation all medical devices for use diagnostic and therapeutic purposes must be registered at the central department of the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), which at the end of a process issued a certificate of registration.
Medical devices in Russia are classified in much the same manner as Europe: class 1 (low risk), class 2a (medium risk), class 2b (increased risk), class 3 (high-risk).
Registration is mandatory for all medical products designed for medical application in the territory of the Russian Federation and including devices, apparatus, instruments, appliances, kits, complexes, systems with software, equipment, accessories, dressing and suture, dental materials, sets of reagents, referencing materials and standard samples, calibrators, analyser consumables, products of polymeric, rubber and other materials, software applied for medical purposes either apart or in combination with each other.
The overall registration process for medical equipment usually takes between four and 12 months.Validity of registration depends on the type of medical device and may be from 5 to 10 years, or for indefinite duration.