+38 044 332-42-94,
+38 044 221-71-29,
Medical devices
— Market requirements for medical devices
— Establishment of marketing authorization
— Renewal of registration and changes
— Dossier structure (necessary documents)
— State registry of medical devices
— Sanitary epidemiological conclusion
— Certification of medical devices
— Ukrainian legislation
— Portfolio

Sanitary epidemiological conclusion

Medical devices that have direct contact with patient (consumer) also require sanitary-epidemiological conclusion for import and sale in Ukraine. Sanitary-epidemiological expertise is performed after state registration of medical device. Same documents that were provided for marketing authorization can be used for sanitary-epidemiological expertise. 

Conclusion is valid up to 5 years. Procedure of renewal or changes (amendments) to the conclusion does not foreseen by legislation. 

Annex to the conclusion should include exactly the same list of products as marketing authorization certificate. 

We are ready to assist you in organization of sanitary-epidemiological conclusion. That work can be performed with marketing authorization, or separately. We will correctly fill the Application for expertise and Annex, we will develop necessary materials, we will submit documents to authorized institute of Sanitary-Epidemiological Authority of Ukraine, we will organize all expertise till issue of original conclusion. In fact we will perfrom all necessary actions ourselves, with your approval on all key issues.

It is obvious that all preliminary advices and consulting are free of charge. 

 Образец санитарно эпидемиологического заключения

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.