Development of medical science attracts implementation of new technologies with use of new medical equipment and new medical products. Any new medical product can be applied in medical practice only after the numerous researches and tests. So, according to Article 38 of the Federal law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation", the address of medical products includes technical tests, toxicological researches, clinical tests, examination of quality.
In details process of clinical tests is described in the National standard of the Russian Federation by GOST P ISO 14155-2014 "Clinical trials. Appropriate clinical practice".
The following definition is given to clinical tests - it is any planned systematic research with participation of the person as the subject undertaken for assessment of safety and/or clinical performance of a concrete medical product.
Similar definition of clinical tests is given also in the resolution of the Government of the Russian Federation of December 27, 2012 No. 1416 "About the approval of rules of the state registration of medical products".
In the above-named resolution of the Government of the Russian Federation of December 27, 2012 No. 1416 the sequence of carrying out clinical tests of a medical product is in details described.
So, according to the 26th paragraph of the resolution of the Government of the Russian Federation of December 27, 2012 No. 1416 the order of the Russian Ministry of Health of March 1, 2013 No. 108 "About the approval of structure of council for ethics in the sphere of circulation of medical products" which issues the conclusions about ethical validity of carrying out clinical tests is issued.
Clinical tests of a medical product are carried out in the medical organizations which, at observance of certain requirements, the Russian Ministry of Health defines. Their list can be found on its official site.
The following requirements are imposed to the medical organizations which are carrying out clinical tests of medical products:
a) existence of the license for implementation of medical activity with the indication of the list of works (services) making medical activity proceeding from appointment and a scope of medical products concerning which tests are carried out;
b) existence in the charter of the medical organization of data:
– about implementation of scientific (research) activity;
– about carrying out clinical tests of medical products;
c) existence of office (chamber) of an intensive care and resuscitation, in case of carrying out clinical tests of the medical products with participation of the person as the subject belonging to classes 2b and 3 depending on potential risk of use;
d) ensuring protection of confidential information.
Clinical tests of medical products
On the website of Roszdravnadzor application form samples about intention to carry out clinical tests of medical products, and also a form of the notice of the beginning of clinical tests of a medical product are posted in the section of medical products. Electronic services "The List of the Medical Organizations Which Are Carrying Out Clinical Tests of Medical Products", and also "The register of the given permissions to clinical tests of medical products" are posted in the same section.
Requirements to evaluating compliance of medical products which is carried out in the form of clinical tests for the purpose of the state registration of medical products are stated in the order Mizdrava of the Russian Federation of January 9, 2014 No. 2n "About the statement of an order of evaluating compliance of medical products in the form of technical tests, toxicological researches, clinical tests for the purpose of the state registration of medical products".