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...
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...
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
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
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...
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...
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...
GOOD LUCK IN THE NEW YEAR!
Dear Colleagues! We congratulate you and wish you prosperity and the achievement of all your goals next year!
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 >>...