Registration Department in Ukraine

Registration of Medical Devices in Ukraine

For the import and distribution of medical devices (MD) in Ukraine they should be registered by the Ukrainian Ministry of Health on the authority of indicators of safety, efficiency and quality expertises. Since 20.06.2012 the registration certificates will be issued with an unlimited expiry date (earlier they were issued just for – 5 years). These ammendments are based on the new regulation of 02.06.2012 No. 548, (the text of the regulation is in Ukrainian, but our managers will help you to understand all important points) which has restructured the registration procedure of medical devices and medical equipment. The registration certificates which have been issued before the 20.06.2012 can be renewed through the usual re-registering procedure after which the approvals will be issued without the limited expiry date.

The list of medical devices to be registered by MoH in Ukraine was defined by the Directive of the State Administration of Ukraine on Medicinal Products No. 51 of May 6th, 2010. This list was annulated and renewed by the Directive of Ukrainian's Ministry of Health No. 478 of 02.07.2012 (The text of the Directive is in Ukrainian). The necessity to indicate the FEACN (Foreign Economic Activity Commodity Nomenclature) in the registration certificate for Medical Device as well as in the application for the registration was annulated through the regulation No. 548 (see above). The question concerning the definition of FEACN was always a disputable question by clearing the goods at customs. Now this question is fully turned over to the competency of customs agency.

The sample
of Registration Certificate

An additional ammendment is the introduction of term "qualified trial". Qualified trial is the control trial of samples of medical devices for the carrying out the evaluation of readiness of the plant to manufacture the devices and defining them to the conformation to requirements of the normative documentation.

If you want to quickly (during maximum two monther after transferring of all necessary documentation) and especially qualitative register your products in the Ukraine, please call us or write to us and we gladly will ask you on all your questions.

The sample of the annex
of Registration Certificate

Food supplements and cosmetic products

Quality Alliance LLC can arrange the registration of Food Supplements (and Biological Active Additives) and Cosmetic Products in Ukraine.

Sergey - Sales director and Head of Regulatory Affairs Department for nondomestic manufactured products

 Phone: +7 (495) 36-315-36
 Mobile: +7 (495) 961-18-21
 Skype: director.sales1

© 2017 Альянс Качества – регистрация продукции, сертификация продукции, разработка технических условий.

(24-hour) +7 (962) 953-75-54
+7 (906) 742-99-90
(Reception) +7 (495) 36-315-36

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