"26.60.13.120

Devices of microwave therapy

availability at the legal entity - the tax resident of member countries of the Eurasian Economic Union of the rights to technical documentation for production of the corresponding products for the term of at least 5 years;

availability in the territory of one of member countries of the Eurasian Economic Union of the service center, authorized to perform repair, after-sale and guarantee maintenance of the corresponding products;

availability at manufacturer of the corresponding products of division of research and development works in the territory of the Russian Federation;

availability of documentary confirmation of implementation in production of finished medical product (the declared description of goods) received as a result of accomplishment of manufacturer of research and development works by division (availability of the registration certificate on the finished medical product (the declared description of goods) developed and implemented in production;

availability at manufacturer exclusive and the rights to the trademark, serving for individualization of products, or right to use of the trademark which owner is the legal entity - the tax resident of the Russian Federation who is not under control of foreign state, and (or) the international organization, and (or) foreign legal entity or physical person, and (or) foreign structure without formation of legal entity (in the presence of the trademark);

availability of the research and production base (own or contractual) located in the territory of one of member countries of the Eurasian Economic Union and necessary for development and production;

availability at the applicant of the rights to the software which is carrying out the basic functional purpose of products;

availability at the applicant of quality management system of the company certified according to requirements of GOST ISO 13485-2017;

all case details, except for fitting, the cases of the main unit used for production assembled, shall be made in the territory of the Russian Federation (this requirement is not applied to applicants whose annual amount of seriality of products for the previous calendar year makes less than 300 units);

installation of electronic components on printed circuit boards in the Russian Federation in the amount making 100 percent;

accomplishment of the following technological transactions in the territory of the Russian Federation:

product development;

assembly of products;

check of functionality of products;

loading and configuring of the Russian-language software;

packaging of products;

use of components (component parts) made in the territory of the Russian Federation and accomplishment in the territory of the Russian Federation the following technological transactions (conditions):

use in case of production of the components made in the territory of the Russian Federation (availability of use of at least one component on each Item for receipt of the corresponding number of points is required):

other components (15 points);

production in the territory of the Russian Federation or use of the components made in the territory of the Russian Federation in case of production (availability of at least one unit on each Item for receipt of the corresponding number of points is required):

the case of the main unit in collection (25 points);

cables (15 points);

payments in collection (25 points);

the software which is carrying out the basic functional purpose of products registered in the unified register of the Russian programs for electronic computers and databases (15 points);

the research and (or) developmental works realized by the Russian legal entities in the territory of the Russian Federation:

the amount of costs for research and (or) developmental works makes 1 point for everyone 0,17 of percent of annual amount of the costs of the subject of activities in the field of the industry for research and (or) developmental works suffered in the territory of the Russian Federation previous calendar year in total amount of revenue of the subject of activities in the field of the industry for the previous calendar year, but no more than 20 points

26.60.13.130

Devices of high-frequency and low-frequency therapy

availability at the legal entity - the tax resident of member countries of the Eurasian Economic Union of the rights to technical documentation for production of the corresponding products for the term of at least 5 years;

availability in the territory of one of member countries of the Eurasian Economic Union of the service center, authorized to perform repair, after-sale and guarantee maintenance of the corresponding products;

availability at manufacturer of the corresponding products of division of research and development works in the territory of the Russian Federation;

availability of documentary confirmation of implementation in production of finished medical product (the declared description of goods) received as a result of accomplishment of manufacturer of research and development works by division (availability of the registration certificate on the finished medical product (the declared description of goods) developed and implemented in production;

availability at manufacturer of exclusive right on the trademark serving for individualization of products, or right to use of the trademark which owner is the legal entity - the tax resident of the Russian Federation who is not under control of foreign state, and (or) the international organization, and (or) foreign legal entity or physical person, and (or) foreign structure without formation of legal entity <12(1)> (in the presence of the trademark);

availability of the research and production base (own or contractual) located in the territory of one of member countries of the Eurasian Economic Union and necessary for development and production;

availability at the applicant of the rights to the software which is carrying out the basic functional purpose of products;

availability at the applicant of quality management system of the company certified according to requirements of GOST ISO 13485-2017;