Ukrainian Scientific Institute of Certification

In connection with the military aggression of the Russian Federation in Ukraine martial law was imposed from 05 hours 30 minutes on February 24, 2022 for 30 days in accordance with the Law of Ukraine dated February 24, 2022 No. 2102-IX “On approval of the Decree of the President of Ukraine “On the imposition of martial law in Ukraine”.

The appointed conformity assessment body Uni-Cert LLC announces the introduction of business continuity planning measures aimed at minimizing risks for customers and employees while maintaining all critical business processes. Our team has moved to remote work has access to the Internet and do everything possible to support work processes.

At the same time, the Chamber of Commerce and Industry of Ukraine confirms that these circumstances from February 24, 2022 to their official end are extraordinary, unavoidable and objective circumstances that prevent the implementation of contracts and regulations due to force majeure.

Accordingly, part of the planned work primarily surveillance procedures, are performed on schedule. Certain adjustments are possible.

The term of all other works, in accordance with the section “Force Majeure” of the agreements, has been extended for a period equal to the term of military aggression of the Russian Federation against Ukraine established by law.

At the same time Uni-Cert LLC does not waive its obligations in any way full-fledged work will be resumed as soon as possible.

Ukraine’s healthcare system is stable. The coordinated work of public authorities as well as enterprises, institutions and organizations belonging to the sphere of their management is a significant contribution to ensuring the rights and freedoms of Ukrainian citizens and unites us in the face of the enemy.

We hope for mutual understanding and further fruitful cooperation.

Glory to Ukraine!

Sincerely,

Director of Uni-Cert LLC

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. […]

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Conformity assessment of personal protective equipment

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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; […]

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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
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08.09.202211.00-15.00
08.09.2022

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

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News

27.07.2022

The entry into force of the Technical Regulations for cosmetic products has been postponed for 2 years

On July 26, 2022, the Cabinet of Ministers of Ukraine adopted a resolution “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine dated January 20, 2021 No. 65” in order to postpone the date of entry into force of the Technical Regulations for cosmetic products and introduce a transitional period in this […]

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08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

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30.05.2022

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC. The seminar showed the great […]

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