02.09.2019 Dear Colleagues!
We attract your attention to the fact that, according to the current legislation of Ukraine, medical equipment that is purchased and used by medical institutions of Ukraine have to comply the requirements of the Technicals Regulations for medical devices approved by the Decrees of the Cabinet of Ministers of Ukraine No. 753 and No. 754 of October 2, 2013, and have a Declaration (or Certificate) of compliance.
In particular, it refers to:
- refrigerators and freezers that are used to storage of blood and it components or other body fluids, organs, parts of organs or body tissues, to storage of vaccines, reagents, medicines, etc. (paragraph 10 of Appendix 2);
- centrifuges for separation of blood on components or to treat body fluids (paragraph 11 of Appendix 2)!
These conditions are checked during accreditation and licensing of a medical institutions, certification in accordance with GMP requirements.
Be careful and prudent when equipping your medical facility!