State registration of medical devices in the Russian Federation

State registration of medical devices in the Russian Federation is carried out by the registering body - the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

After successful completion of the state registration procedure, information about the registration certificate is entered into the State Register of medical devices and medical equipment.

A prerequisite for the state registration of a medical device manufactured outside of Russia is the presence of an authorized representative of the manufacturer - a resident of Russia

Types of products subject to mandatory registration as medical devices

Medical equipment:

• Devices for cosmetology and surgery;
• Diagnostic equipment (X-ray equipment, ultrasound machines, etc.);
• Analyzers and other laboratory equipment;
• Products for in vitro diagnostics;
• Technically sophisticated means of rehabilitation (electric wheelchairs, robotic prostheses, etc.);
• Life support devices (IVL, dialysis, etc.);
• Therapeutic devices (ultrasound, radio frequency therapy, etc.);
• Dental units;
• Implants;
• Other equipment used for medical purposes.

Medical products:

• Clothing, shoe covers and other general hospital medical products;
• Consumables (reagents, replaceable filters, ECG paper, etc.);
• Standard samples, calibrators for analyzers;
• Suture surgical material;
• Bandages and other dressings;
• Surgical instruments;
• Viewing instruments;
• Medical furniture;
• Orthoses;
• Other products used for medical purposes.

Specialized software:

• Software for image analysis from diagnostic equipment;
• Software for managing the information system of medical institutions;
• Software for telemedicine;
• Other software used for medical purposes. 

To form a registration dossier (a set of documents required for registration of a medical device), the following documents will be required:

• Documents on registration of the manufacturer as a legal entity (in the country of production);
• Manufacturer's certificates (if available);
• Permits for the registered product (if any);
• Power of attorney for the authorized representative of the manufacturer in the territory of the Russian Federation;
• Documents confirming the conditions of production;
• Technical file;
• Operational documentation;
• Photos of the product being registered.

1 class                   from 6 months.

2a and 2b class     from 8-10 months.

3 class                   from 12 months.

The cost of the service is from $37,000 to $73,500 for one registration certificate