Ukrainian Scientific Institute of Certification
+38 044 227-41-46
+38 044 338-07-82
Kiev, Kudryavsky descent 7, office 320
Policies and procedures
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...
VIII INTERNATIONAL MEDICAL FORUM, April 25 – 27, 2017
VIII INTERNATIONAL MEDICAL FORUM “Medicine Innovations – the Nation’s Health” – large-scale complex innovation-oriented event of the health care industry of Ukraine, combined a powerful scientific-practical program, schools, specialized exhibitions, created an information platform for the exchange of experience and improvement of professional s...
Summary of the workshop “Conformity assessment of domestically made medical devices”
On 23 March, the workshop titled “Conformity assessment of domestically made medical devices” took place and was attended by 20 employees of Ukrainian manufacturers of medical devices. For many of them, the transition to conformity assessment is an extremely complicated and costly task, as it requires implementation of standards of production quali...
Сonformity assessment of domestically made medical devices, 23 march 09:30–18:00
On 1 July 2015, conformity with the Technical regulations on medical devices became mandatory in Ukraine, and in less than six months ends the transition period, during which medical devices may be placed on the market on the basis of previously granted registration certificates. For most national manufacturers, the transition to conformity asse...
Summary of the workshop “Specific Features of Assessment of Conformity of Medical Devices with the Technical Regulations for Pharmaceutical Companies”
On 3 March, a workshop titled “Specific Features of Assessment of Conformity of Medical Devices with the Technical Regulations for Pharmaceutical Companies” took place and was attended by 16 listeners working for the companies whose portfolios include the following products: medical devices supplied with a medicinal product; medical devices...
Results of the workshop Practical Experience of Conformity Assessment of Foreign-Made Medical Devices
On 24 February, the workshop Practical Experience of Conformity Assessment of Foreign-Made Medical Devices was held. The event was attended by 21 listeners from 16 companies and organizations operating on the market of foreign-made medical devices and equipment, and in vitro diagnostic medical devices. The workshop began with the opening speech ...
Practical experience of conformity assessment of foreign-made medical devices, 24 February 10.00–18.00
This event has been prepared for representatives and distributors (importers) of foreign-made medical devices, equipment, and in vitro diagnostic devices. During the event, we will talk in detail about the following topics: designation of a manufacturer`s authorised representative in Ukraine, his functions, duties, rights and risks; requ...
Ukrainian Research Institute of Certification has changed location!
Dear colleagues! Ukrainian Research Institute of Certification has changed location, now we are at: 7 Kudryavsky descent, office 320 04053, Kiev, Ukraine Phone / Fax: +38 (044) 338-07-82 +38 (044) 227-41-46 Work schedule: Monday - Thursday from 9.30 to 18.00 Friday from 9.30 to 17.00 without break
Cabinet of Ministers Resolution Extended Transition Period for Technical Regulation on Medical Devices Until 1 July 2017
On 15 April 2016, Resolution No. 240 of the Cabinet of Ministers of Ukraine of 23 March 2016 on amendments to certain resolutions of the Cabinet of Ministers came into effect. The Resolution allows medical devices that have been registered with the state and entered into the State Register of Medical Equipment and Devices to be importe...
Notified body representatives took part in the 5th anniversary ukrainian forum of medical device market operators
On 7 April 2016, the Rus Hotel, Kyiv, became the venue for the 5th anniversary Ukrainian forum of medical device market operators The forum highlighted the economic situation and international experience with regard to the medical device market functioning and its specific directions. An interactive focus session with regulators re...