How to Get a Medical Device Approved according to new Ukrainian Regulations?

Dear Colleagues,

As it was mentioned previously, 1 July 2015 was the date of enforcement for the new medical device approval procedures in Ukraine. In this post I would like to provide more details for better understanding of new Ukrainian medical device regulation system:

I.Transition Period

Products already registered in Ukraine for 01 July 2015 will be permitted for importation until 1 July 2016 or until the expiration date of the product’s registration (if this date is earlier than 1 July 2016). Registration cannot be renewed or prolonged.

Products already registered in Ukraine for 01 July 2015 will be permitted to be commercialized and used in clinics by the end of shelf-life of exploitation period mentioned in the IFU.

II. New approval process:

Please see the description of new process in the slideshare chart:

III. Useful links:

Technical regulation #753 – Medical devices (link in Russian)
Technical regulation #754 – In vitro diagnostic devices (link in Russian)
Technical regulation  #755 – Active implantable medical devices (link in Russian)
Decree #181 dated 27.05.2015 On transition period (link in Ukrainian)
List of notified bodies accredited by Ukrainian MoH
Ukrainian conformity assessment mark

7 thoughts on “How to Get a Medical Device Approved according to new Ukrainian Regulations?

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