Ukrainian Scientific Institute of Certification
08/10/2018
The 27th International Medical Exhibition “PUBLIC HEALTH 2018” took place on October 2-4
Within the framework of this exhibition, UNI-CERT held two seminars on topical issues: “Medical devices turnover by certificates of the body that has lost its accreditation and appointment. Change of conformity assessment body” and “Procedure of recognition of medical devices conformity assessment results, conducted by European Notified bodies (Rec...
01/10/2018
Seminar “Medical device conformity assessment through EC-certificates recognition”
Dear participants of the 27th International Medical Exhibition ‘PUBLIC HEALTH 2018’! Since July 1st, 2017 medical devices import and placing on market is possible only through the mandatory application of Technical regulation. Audit of production is the most commonly used way of assessing the compliance of medical devices. But, if the product has ...
18/09/2018
Seminar “Enforced change of conformity assessment body. Transfer procedure.”
Dear participants of the 27th International Medical Exhibition ‘PUBLIC HEALTH 2018’! This year, the National Accreditation Agency of Ukraine (NAAU) has canceled the accreditation and appointment of several bodies for assessing the compliance of medical devices. Manufacturers and distributors who placed their products on the market on the basis of ...
Exhibition «PUBLIC HEALTH 2018»
The exhibition PUBLIC HEALTH is the first international event in Ukraine and the fourth in Europe. Every year PUBLIC HEALTH attracts more than 300 leading manufacturers and distributors of equipment, services, medicines, medical products from Ukraine and other countries. We invite you to visit our exhibition stand M1-3 and learn about our capa...
12/09/2018
A contract on recognition of the results of the assessment of conformity with Kiwa Belgelendirme Hizmetleri A.Ş.
Dear colleagues! We are pleased to inform you that the notified body Kiwa Belgelendirme Hizmetleri A.Ş. (1984) 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 certificatio...
29/08/2018
WHO workshop on post-market surveillance of in vitro diagnostics (IVDs) for testing providers and regulators in Ukraine
On August 28-29, 2018 in Kiev, the World Health Organization (WHO) held a workshop on post-marketing surveillance for in vitro diagnostic medical devices (IVDs) for testing providers and regulators in Ukraine. Within the framework of this event, Anna Telpiakova, Quality Assurance Deputy Director of UNI-CERT LLC, presented the report "Post-marke...
28/08/2018
A contract on recognition of the results of the assessment of conformity with Presafe Denmark A/S
Dear colleagues! We are pleased to inform you that the European notified body Presafe Denmark A/S (0543) 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 t...
10/08/2018
A contract on recognition of the results of the assessment of conformity with Bureau Veritas Italia S.P.A.
Dear colleagues! We are pleased to inform you that the European notified body Bureau Veritas Italia S.P.A. (1370) 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 certifica...
09/08/2018
UNI-CERT started issuing certificates on new sample forms
Due to the fact that the National Accreditation Agency of Ukraine became a signatory of the IAF MLA, the conformity assessment bodies that are accredited by NAAU have the opportunity to use the combined IAF MLA mark on their certification documents provided that the corresponding license agreement with NAAU is signed within the NAAU recognition are...
23/07/2018
The Ukrainian MOH has a plan to implement GMDN-classifier of medical devices
The Ministry of Health of Ukraine plans to integrate GMDN (Global Medical Device Nomenclature), the international nomenclature of medical devices, into the electronic ProZorro Procurement System. Such the integration will allow to optimize the purchase of medical devices by health care institutions and to prevent possible manipulations by their nam...