Ukrainian Scientific Institute of Certification

it is a modern competent body, that fulfills all aspects of Ukrainian legislation and is guided by EU law. The body is fully independent and impartial in its decisions which are based solely on objective evidence of conformity. We have much to be proud of:

  • More than 400 international medical device manufacturers from 37 countries worldwide have expressed their trust in us
  • We conduct audits and document assessments in English and German
  • We have concluded agreements on the recognition of conformity assessment results for medical devices with leading European notified bodies and laboratories

Take a closer look and learn from our clients about the expertise level of our specialists to make effective decisions for your business!

Our services

Conformity assessment of medical devices

Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]

Read more

Conformity assessment of personal protective equipment

Read more

Quality Management System Certification

The presence of a certified Quality Management System (QMS) provides the company with a number of advantages: The efficiency and effectiveness of processes are optimized and increased; The quality of products and/or services improves; The company becomes one that independently improves and develops, requires less attention from the company’s management; The effectiveness of decision-making increases; […]

Read more

We are trusted

by more than 350 international medical device manufacturers since:

  • Our team consists of 39 full-time and 20 freelance specialists
  • Our experience is more than 500 audits in 35 countries in Ukrainian, Russian, English and German languages
  • We have entered into Agreements on recognition of conformity assessment results with leading European notified bodies
Read more

Upcoming events


Formation of a technical file for medical devices

Read more

Quality management system at enterprises importing and selling medical devices. General information.

Read more



A webinar “Update of Technical Regulations in the Field of Medical Devices. Changes to be Prepared for.” took place

Text is available only in Ukrainian

Read more

Formation of a technical file for medical devices

The program of the event is available only on Ukrainian

Read more

All about the authorized representative

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian

Read more

Ask your question

Or find the answer here

*All fields are required