of May 24, 2010 No. 774
About approval of the technical regulation of the Republic of Belarus "Medical products. Safety" (TP 2010/006/BY)
According to the paragraph the sixth article 8 of the Law of the Republic of Belarus of January 5, 2004 "About technical regulation and standardization" the Council of Ministers of the Republic of Belarus DECIDES:
1. Approve the enclosed technical regulation of the Republic of Belarus "Medical products. Safety" (TP 2010/006/BY) (further the technical regulation) and to enact it since January 1, 2015.
2. To the Ministry of Health, State committee on standardization:
together with interested to develop and approve the actions plan on enforcement of the technical regulation;
approve the list of the technical regulatory legal acts interconnected with the technical regulation and provide its permanent updating.
3. To provide to republican state bodies till January 1, 2015 reduction of the technical regulatory legal acts in compliance with this resolution.
4. This resolution becomes effective from the date of its official publication.
First deputy of Premier-inistra
Republic of Belarus V. Semashko
Approved by the Resolution of Council of Ministers of the Republic of Belarus of May 24, 2010, No. 774
1. This technical regulation extends to the released medical products and belongings to them (further - medical products):
new, earlier not being in operation, irrespective of country of source;
being in operation, imported into the Republic of Belarus.
Products of medical appointment, measuring instrument of medical appointment and the medical equipment which are turning on any tools, devices, devices, devices, software, implants, materials or other similar or related products applied separately or in combination with other medical products and intended for belong to medical products to which this technical regulation extends:
diagnostics, prevention, observation and treatment of disease or injury;
medical rehabilitation and prosthetics;
maintenance or providing life;
control over conception.
This technical regulation extends including to medical products:
which influence human body not directly, and by means of other medical product;
in the course of which use simultaneous use of the substances and components which are separately considered as medicines or pharmaceutical substances including received from blood and plasma of the person is to destination supposed.
Medical products to which this technical regulation extends do not influence human body by means of pharmacological, immunological or metabolic means, but their impact can be supported by these means.
2. This technical regulation does not extend on:
the active implanted devices;
the equipment for laboratory diagnostics of in-vitro (out of organism);
medicines;
cosmetic products;
blood of the person, products from blood, plasma or blood cages of human origin;
products which part at the time of placement in the market products from blood, plasma or cages of human origin are;
transplants, fabrics or cages of human origin, and also the products containing fabrics or cages of human origin;
transplants, fabrics or cages of animal origin, except for the products made using the cages of animal origin deprived of viability, or impractical products received from tissues of animals;
the medical products intended for the research works which are not connected with diagnostics or treatment of the population;
individual protection equipment.
3. This technical regulation establishes safety requirements to medical products for the purpose of protection of life, health and heredity of the person, and also the prevention of actions, the misleading users (consumers) of medical products concerning their appointment and safety.
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The document ceased to be valid since January 1, 2015 according to Item 1 of the Resolution of Council of Ministers of the Republic of Belarus of December 31, 2014 No. 1287.