In Ukraine, Medical Devices are regulated by the Ministry of Health (MOH). Medical products whether they are manufactured or imported into Ukraine must be registered with MOH. Medical devices in Ukraine are divided into four classes (I, IIa, IIb and III) based on risk level. A local representative is not required to register a medical device in Ukraine.

Our country specific (*) services in Ukraine include:

Medical Device specific regulation strategy reports, Medical Device Registration with the MOH, MOH Technical File and Design Dossier preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Ukraine!

(*) Ukrainian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.