Clinical trials are designed and planned systematic studies undertaken, including with the participation of a human subject, to evaluate the safety and efficacy of a medical device.

During the initial registration of a medical device, these tests are carried out for the first risk class immediately after technical testing and toxicological studies, however, for other risk classes, a permit is required issued by Roszdravnadzor after the first stage of the examination.

Clinics
Tests are carried out exclusively by accredited clinics.

All protocols undergo additional internal verification by staff specialists.

Cost calculation
List of required information for calculating the cost of conducting clinical trials:

• Name of the medical device;
• Purpose and scope;
• Operational documentation;
• Technical documentation;
• Toxicological studies;
• Technical tests;
• The materials from which the medical device is made;
• Table of registered analogues;
• Clinical reports, testimonials, etc.