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Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

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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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Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]

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