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We would like to inform you about significant changes in registration and quality management of medicinal products in Ukraine.
 

On June 17, 2020, the IX Ukrainian Forum of Medical Device Operators was held, which traditionally discussed the most relevant topics related to taxation, prices and technical regulation of national medical devices market, personal protective equipment and disinfectants.

EU recognition of certificates, remote audits and approvals in the interest of health: how certification of medical devices goes in a global pandemic

The pace and geography of the spread of coronavirus infection has been a source of tension for the world community for the several last months. Many countries have closed borders and restricted traffic within the country as preventive measures for the spread of COVID-19.

Today the issue of the spread and prevention of coronavirus infection (COVID-19) is one of the most discussed and acute. World organizations and governments take active actions daily, relying on the relevant support from business. 

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 each company and citizen.

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. 

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 the Cabinet of Ministers of Ukraine No.

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 Ukraine, including:

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.