Ukrainian Scientific Institute of Certification
27/03/2020
Expansion of the scope of accreditation
UNI-CERT LLC passed a scheduled audit and expanded its scope of accreditation. In accordance with new the accreditation certificate No. 80103 of 03.03.2020 and the scope of accreditation (Annex of July 26, 2020; Annex of March 03, 2020), UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) accordin...
Additional information on temporary changes in the import of medical devices
  Detailed information of the Ministry of Health of Ukraine is here
25/03/2020
Information on temporary changes in the rules for the import of medical devices
  Detailed information of the Ministry of Health of Ukraine is here
23/03/2020
New legislative acts to prevent COVID-19
The Cabinet of Ministers of Ukraine adopted legislative acts in order to establish a legal framework for the prevention and treatment of coronavirus disease (COVID-19): Resolution of the Cabinet of Ministers of Ukraine No.224 "On Approval of the List of Medicinal Products, Medical Devices and/or Medical Equipment Required for Implementation of M...
17/03/2020
ANNOUNCEMENT!
  Dear Colleagues and Partners! Due to force majeure circumstances caused by the pandemic of the Covid-19 virus in the world and its spread in Ukraine, UNI-СERT LLC has introduced changes to the working hours of its office. From March 18, one part of our staff will be available remotely, the other part will work in the office with a f...
03/02/2020
European Notified Bodies with whom agreements on recognition of conformity assessment results have been signed
Due to the increase of the quantity input of requests on the procedure of the recognition of European Notified Bodies conformity assessment results in relation to medical devices, we inform that at the moment UNI-CERT LLC has signed the agreements on recognition of conformity assessment results with: 1.  TÜV SUD Product Service GmbH (0123) 2....
23/01/2020
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 bi...
01/01/2020
GOOD LUCK IN THE NEW YEAR!
Dear Colleagues! We congratulate you and wish you prosperity and the achievement of all your goals next year!
23/09/2019
X Anniversary International Exhibition “PHARMATechExpo 2019” took place on September 17-19
Within the framework of this exhibition, UNI-CERT held seminar on topical issues: «Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices». About 100 participants of the event improved their professional level and received answers to their questions. Photo report >>...
18/09/2019
Interview of the UNI-SERT management for the Pharmacy Weekly
The Ukrainian Scientific Institute of Certification is rapidly expanding its ambitions: expanding the range of services, modernizing the laboratory and constantly finding new ways to increase the efficiency of its own activities. The largest Ukrainian medical publication Pharmacy Weekly became interested in the reasons for such changes. Management ...