Clinical trials

Clinical trials  of medical devices are carried out in the form of research and in the form of tests, including with 
participation of human being carried out to assess the safety and efficiency of the medical product.

Clinical trials  of medical devices involving a  human being are held in the following cases:

a) a new type of medical product;

b) the use of new complex and (or) unique and (or) special methods for the prevention, diagnosis and treatment of diseases and
states, as well as the use of new complex medical technologies;

c) If the effectiveness and safety of the medical product is not confirmed during analysis and assessment of clinical data.
 In other cases, clinical tests of medical devices are carried out in the form of analysis and assessment of clinical data.

When they are reviewing  the presented documentation for the medical device, they must consider, the program and the duration of 
trials of the medical device. The duration of clinical trials is determined by the functional  and complexity of medical
device. The clinical trial program is compiled by the applicant together with the medical organization carrying out
clinical trial of the medical device, in accordance with the requirements specified in the technical and
operational documentation, as well as the requirements of regulatory documentation.

When carrying out clinical trials, must be;
a) analysis and evaluation of clinical data of documents and materials submitted by the applicant in accordance with paragraph 38
of this order;

b) an assessment of information about the clinically significant corrective actions, including suspension of application
medical product, about withdrawal from the appeal of the medical product, about the reviews of the medical product;

c) analysis of scientific literature and (or) unpublished data and communications related to the designed manufacturer
use of the test medical device and the proposed method of its use;

d) drawing up a clinical trial program;
e) testing of samples (sample) of the medical product in case of tests with human participation;

(e) Refinement of the manufacturer's operational documentation for a medical product based on test results (if necessary);

g) registration and issuance (presentation or direction by registered mail with a notice of a presentation) to the applicant act
Estimates of the results of clinical tests of the medical product.

During clinical trials, it is determined:
a) compliance with the medical product of regulatory documentation, technical and operational documentation of the manufacturer;
b) compliance with the applicant's documentation by the applicant by the manufacturer's intended purpose and indications for use;

c) fullness and accuracy of the manufacturer's technical and operational documentation established by the regulatory
characteristics of the medical product;

d) the quality of the medical product, the efficiency and safety of its application, including the expected therapeutic effect in
 the relationship of medical devices used for therapy.

 The cost of clinical trials primarily depends on the following parameters:

a) class risk class;

b) appointment of a medical product;

c) the number of sample execution;

d) methods and shape of the test.

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