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. […]

Definition of the class of medical devices

EU-certificates recognition

On February 10th 2016, the Law of Ukraine “On Technical Regulations and Conformity Assessment” came into force, article 45 of which describes the possibility of recognizing the results of conformity assessment performed in another country. There are several options for recognition, and with respect to each of the options, the Law sets forth the appropriate conditions. Since Technical […]

ISO 13485 certification of manufacturer, importer and reprocessor

GMP certification of cosmetic production

Decree of the Cabinet of Ministers of Ukraine dated January 20, 2021 No. 65 approved the Technical Regulation for cosmetic products, which was developed on the basis of the Regulation on cosmetic products (EU) No. 1223/2009 of the European Parliament and of the Council of November 30 , 2009. For the sale of cosmetic products […]

Laboratory product testing

The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated May 09, 2025. The laboratory’s scope of activities covers the testing of the following products: medical devices, namely […]

Education and training

The main specialization of the UNI-CERT Training Center is the advanced training of quality managers and regulatory managers of suppliers, distributors, manufacturers of medical devices and cosmetics. In addition, regular internal training of our own employees is carried out. In addition to the main topics that are in constant demand among most market participants, the […]

Information services

The Ukrainian Scientific Institute of Certification provides information services exclusively within its competence related to medical devices, personal protective equipment and certification of quality management systems. Thanks to the experience of cooperation with the largest suppliers and manufacturers on the Ukrainian market, concluded agreements on the recognition of the conformity assessment results with leading European […]