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The Procedure entry into Ukraine unregistered medical equipment and medical supplies

MOH Order of 30.11.2012 N 979 approved approved the entry into the territory of Ukraine unregistered medical equipment and medical supplies, which establishes requirements for the importation of unregistered medical equipment and medical devices and applies to business entities that intend to import unregistered medical equipment and medical products.

 
According to the procedure, medical equipment and medical supplies that are not registered in Ukraine in accordance with the law, may be imported into the territory of Ukraine:
  • for the purpose of state registration (re-registration) of medical equipment and medical devices;
  • to participate in the program of technical assistance programs of international cooperation in accordance with international agreements;
  • in case of natural disasters, accidents, epidemics and epizootics, environmental, technological disasters (by separate Cabinet decision taken in accordance with the law).

For the message about the possibility or impossibility of import to Ukraine unregistered medical equipment and medical entity that intends to import unregistered medical equipment and medical supplies to Ukraine, shall submit to Hosleksluzhby statement addressed to the Head Hosleksluzhby in stating the purpose of importing unregistered medical equipment and medical supplies, their name, number, manufacturer, country of manufacture, the list of supporting documents.

The application shall be accompanied by the documents specified in addition to the consideration Poryadku.Srok full documentation and notice the possibility of import to Ukraine unregistered medical equipment and medical devices should not exceed 5 working days.

Order was registered with the Ministry of Justice on December 20 in 2012, N 2124/22436 and shall become effective from the date of its official publication.

 
Material: All-Ukrainian Network League: LAW
www.ligazakon.ua

 


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