Ukrainian Scientific Institute of Certification
20/05/2020
The Ministry of Economy of Ukraine provided an explanation regarding the unilateral recognition of EС-certificates
In early March 2020, the Association of Market Operators of Medical Devices (AMOMD™) sought professional advice on technical issues regarding legality and legality of assessing the conformity of medical devices to the requirements of relevant technical regulations by recognizing the results of conformity assessment carried out by notified bo...
14/05/2020
The government has amended the technical regulations No. 753, 754 and 755
The Cabinet of Ministers of Ukraine published the Resolution of 05/06/2020, No. 347, which amended the Resolutions No. 753, No. 754 and No. 755, which approved the technical regulations for medical devices.
27/04/2020
Follow-up audit of NAAU for compliance with the requirements of DSTU ISO/IEC 17025:2017
The National Accreditation Agency of Ukraine (NAAU) conducted annual follow-up audit to determine the level of compliance with the requirements of DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” of the testing laboratory of the Limited liability company “Ukrainian Scientific Institute of Certific...
21/04/2020
Be attentive! Cases of certificate falsification became more frequent!
Sorry, this entry is only available in Ukrainian and Russian.
10/04/2020
Uni-Cert, LLC introduced a mechanism for conducting remote audit (audit by telecommunication)
  Due to the rapid growth of the COVID-19 pandemic, in view of the safety and well-being of the population, governments in the most countries of the world have introduced restrictive measures, including the introduction of a ban on passenger transportation, including air travel. Many countries have closed borders for foreign nationals. C...
08/04/2020
European Commission postpones application of the Medical Devices Regulation (EU) 2017/745 to prioritize the fight against coronavirus
On April 3, 2020, the European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation (EU) 2017/745 to allow Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of...
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...
26/03/2020
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 and personal protective equipment
  Detailed information of the Ministry of Health of Ukraine is here Detailed information of the State Service of Ukraine for Labor 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...