Ukrainian Scientific Institute of Certification
15/08/2017
Regarding the market of medical devices in Ukraine as a result of July 2017
According to the analytical system of market research "Pharmstandard"/ "PharmXplorer" of the company "Proxima Research", the market of medical devices in Ukraine continues to grow. In monetary terms, the volume of retail sales in pharmacies increased by 15.6% (431.7 million UAH) as compared with July 2016 (373.5 million UAH.). And in physical te...
03/08/2017
Regarding market surveillance of medical devices in Ukraine since June 20, 2017
Since June 20, 2017 State Administration of Ukraine on Medicines and Drugs Control  and its local departments are authorized to carry out market surveillance of medical devices, legalized through conformity assessment procedure to Technical regulation requirements in edition of 2013. It became possible through official publication in the newspaper ...
28/07/2017
Results of the seminar “Legislation of medical devices in Ukraine since July 2, 2017”
On July 27, 2017 another training seminar was held, organized through the cooperative efforts of the Association of market operators of medical devices (AMOMD), Cratia and Ukrainian Scientific Certification Institute, with a focus on legalization of medical devices after the transition period, the recognition of conformity assessment results and co...
24/07/2017
On the rules for determining the cost of works on conformity assessment carried out by notified bodies
The government has approved the Rules for Determining the Cost of Works on Assessment of Conformity with the Technical Regulations Carried Out by Notified Bodies and Recognized Independent Organizations. The corresponding Resolution of the Cabinet of Ministers of Ukraine (No. 514 dated 12 July 2017) is published on the government portal. It should...
22/07/2017
Seminar ‘Legislation of medical devices in Ukraine since July 2, 2017’
On July 27, 2017 Uni-Cert specialists will take a part in the seminar titled: ‘Legislation of medical devices in Ukraine since July 2, 2017: ended of the transition period, CE Certificates recognition, surveillance audits and changes to the certificate of conformity, Market surveillance’ The seminar will focus on the most topical issues of confor...
14/06/2017
Business Forum of the Improving Healthcare in the Service of People Project
On 9 June, a business forum on medical devices was held as part of the Improving Healthcare in the Service of People Project. The event was organized by the Ministry of Health or Ukraine in cooperation with the International Bank for Reconstruction and Development and with the support from the Association of Medical Operators for Medical Devices (A...
09/06/2017
Labelling of medical devices and instructions for use, and manufacturers’ names and locations in the Ukrainian language
Dear colleagues! On July 1, 2015, the Technical Regulations on Medical Devices (Resolution of the CMU No. 753 dated October 2, 2013), the Technical Regulations on Medical Devices for In Vitro Diagnostics (Resolution of the CMU No. 754 dated October 2, 2013), the Technical Regulations on Implantable Active Medical Devices (Resolution of th...
01/06/2017
A contract on recognition of the results of the assessment of conformity with ITALCERT S.r.l.
Dear colleagues, We are pleased to inform you that the European notified body ITALCERT S.r.l. has signed an arrangement for the recognition of conformity assessment results with the limited liability company UNI-CERT. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their prod...
28/04/2017
Summary of the workshop “REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS”
On 20 April 2017, the workshop titled "REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS" took place. In 4 hours of this club-format event, the participants addressed these topics in more detail and received the answers to all their questions of interest that are not always answered by experts in the course of larger events, let alone ill...
18/04/2017
REQUIREMENTS OF ISO 13485 | INTERNAL AUDITS | RISK ANALYSIS, 20 April 10:00–14.00
On 1 July 2015, conformity with the Technical regulations on medical devices became mandatory in Ukraine, and on 1 July 2017 ends the transition period during which medical devices are allowed to be placed on the market on the basis of previously granted registration certificates. For most market participants, the transition to conformity assessmen...