Technical laboratory testing medical devices in Russia

Technical lab testing of medical devices are carried out in the form of tests and (or) evaluation and analysis of data to verify 
the quality and safety of the medical product when using it in accordance with the purpose provided for by the manufacturer's 
When evaluating and analyzing data, it is carried out:

a) analysis of data of technical literature and information related to safety, operational and specifications, as well as to 
the prescribed use of the medical product;

b) analysis of the results of the tests of the medical product test;
c) Analysis of the conditions for the production of a 
medical product.

When conducting technical tests:

a) identification of the medical product;
b) definition and coordination with 
the applicant of the type of medical product and the class of potential risk of using a medical product in accordance with the 
nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation;

c) analysis of the technical documentation of the manufacturer on the medical product;
d) compiling technical testing programs (when conducting tests);
e) test of samples (sample) of the medical product (when 
conducting tests);

(e) Evaluation and analysis of data related to the medical product, to check its quality and safety;

g) finalization of the technical and operational documentation of the manufacturer to the medical device according to the 
results of technical testing, in terms of determination:
completeness and adequacy requirements that ensure the quality and 
safety of the medical product;
compliance with the requirements set forth in the manufacturer's technical documentation for a 
medical product, the requirements of applicable national (international) standards;
h) Registration and issuance to the 
applicant an act of evaluating the results of technical testing of a medical product.

The technical testing program is compiled together with the applicant. The program and techniques of technical testing 
approves the head of the test organization conducting technical testing.

During technical testing, it is determined:

a) the compliance of the medical product with the requirements of applicable national (international) standards, as well as 
regulatory documentation, technical and operational documentation of the manufacturer;

b) compliance with the applicant's documentation with the requirements of applicable national (international) standards and 
regulatory documentation for a medical product;

c) completeness and objectivity of the manufacturer of characteristics to be monitored in technical documentation to be 
controlled during technical testing, as well as test methods;
d) the possibility of using the manufacturer's operational documentation when applying a medical product for its intended 

e) the quality of the medical product and the safety of its use.

The cost of technical testing depends on:
a) the risk of the use of the medical product;

b) the appointment of a medical product;

c) the number of execution of samples declared in the manufacturer's technical documentation (manufacturer);

d) methods of testing medical products.

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