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After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory documents of the health sector. It should be noted that affixed CE mark at the product, as well as availability documents, which confirm compliance to the European Directives on medical devices, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure.
PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates
Read moreOn August 31, the 12th Ukrainian Forum of Medical Devices Market Operators was held, which provided manufacturers, suppliers, distributors, and importers of medical devices with a platform for solving all urgent issues, discussions, recommendations, and sharing valuable experience in doing business during martial law. The Ukrainian Scientific Institute of Certification traditionally sponsored this event. In […]
Read moreDear volunteers, friends, colleagues! The Ukrainian Scientific Institute of Certification has its own accredited testing laboratory, which provides laboratory testing for compliance with the requirements of 49 international and domestic standards for 146 test methods for medical devices and personal protective equipment. If you or your partners need to conduct laboratory tests of products supplied […]
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