Ukraine. Importation of unregistered medical equipment and medical products to Ukraine

On 18 January 2012 order of Ministry of Health of Ukraine (“MHS”) № 979 dated 30 November 2012 “On adoption of the procedure of importation to Ukraine of unregistered medical equipment and medical products.”

The procedure provides for the requirements for importation of unregistered medical equipment and medical products, and applies to business entities that intend to import unregistered medical equipment and medical products to Ukraine.

Unregistered medical equipment and medical products can be imported to Ukraine:

for the purposes of state registration (re-registration)
to participate in the technical assistance programs of international cooperation in accordance with international treaties and
in the case of natural disasters, accidents, epidemics and epizootics, environmental and man-made disasters (subject to the CMU’s separate decision).

To receive permission for such importation the applicant should submit their application and certain documents to the State Service of Ukraine on Medicines. After due consideration, the State Service of Ukraine on Medicines no later than in 5 working days will notify the applicant on the possibility to import unregistered medical equipment and medical products to Ukraine.

Source: KPMG Ukraine