Сonsultation

COVID-19: exemption from VAT, simplified procurement and registration, impact on regulatory

22.03.2020

Not so long ago, the world community was shaken by the news about cases of pneumonia caused by an unknown pathogen, and today the issue of spread and prevention of coronavirus infection (COVID-19) is one of the most discussed and acute, both at the level of global organizations and states, and at the level of […]

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COVID-19: quarantine impact and BCP

19.03.2020

Due to the rapid development of COVID-19 coronavirus infection, considering the safety and well-being of our colleagues and partners, we inform about the plans of our organization for the duration of the pandemic.  From March 16, 2020, for an indefinite period of time, Cratia has activated the Business Continuity Plan (BCP) aimed at minimizing risks […]

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Guidelines for medical devices and update of harmonized standards

11.02.2020

On January 22, Order of the Ministry of Health of Ukraine No. 142 “On Approval of Methodological Recommendations on Application of Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013, Technical Regulations on medical devices for in vitro diagnostics approved by Resolution of […]

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Important: SI units on the package labeling in UA

30.01.2020

The transition period for placing of products into circulation with measuring information in SI units on the labeling will come to an end in 11 months, on 01.01.2021. The requirements of the Order of the Ministry of Economic Development No. 914 of 04.08.2015 apply to all products that will be placed on the market of […]

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News on labeling of food products in Ukraine

24.12.2019

In accordance with the Association Agreement, Ukraine is harmonizing their legislation with Eropean Union. As a result, within 2019 in Ukraine several legal acts came into force establishes the legal and organizational basis for providing consumers with information and affected the labelling of food products, including dietary supplements, child and medical foods. We have issued […]

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News on the labeling of food products in Ukraine

31.10.2019

We would like to inform you on the recent news concerning the food products in Ukraine. The Language Law. On July 16, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as State Language” came into force. The law stipulates that the only state (official) language in Ukraine is Ukrainian language, however it […]

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How does Brexit impact the medical devices market of Ukraine?

30.10.2019

News under the tag “Brexit” appear in Ukrainian mass media more and more frequently, describing various aspects of the UK politics and economics. Considering new development vector of any country, first of all we must consider the political process with hardly predictable multi-level impact on certain economic realm, industries and production. It is important not […]

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Recognition of EC certificates for medical devices in Ukraine

08.10.2019

About three years ago the first Agreement on recognition of conformity assessment results was signed by notified body TÜV SÜD. This agreement started national conformity assessment of medical devices from the European market in a faster, more economical and transparent way. At the present moment about 30 EU notification bodies have signed such Agreements with Ukrainian […]

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Overview of changes in legislation on medical devices in Ukraine

20.09.2019

We inform you on the most actual news regarding medical devices in Ukraine in June, July and August 2019.  Technical regulations and market surveillance. On July 3, amendments to the Law of Ukraine ‘On Technical regulations and conformity assessment’ came in force. Amendments were introduced under the Law ‘On amendments to certain legislative acts of Ukraine […]

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We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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