The seminar will be held at the exhibition “PHARMATechExpo 2020” on October 28
October 28, 14.30 - 17.30 | hall №2 Seminar «Medical products in the range of pharmaceutical manufacturers. Conformity assessment of medical devices for in-vitro diagnostics» Registration Organizer: UNI-CERT, LLC
UNI-CERT received new accreditation certificates for the next 5 years
The 5-year accreditation period of the Ukrainian Scientific Institute of Certification has ended this year. Over the years, our team has grown by almost 80%, held more than 150 seminars and webinars, made several dozen publications in specialized media, and started cooperation with 27 leading European notified bodies. During this time, we have b...
Labelling of medical devices for exhibitions
Dear exhibitors of InterCHARM-Ukraine, Pro Beauty Expo, Public Health, International Dental Forum! Market surveillance authorities have strengthened monitoring of medical devices exhibited at the expositions. Therefore, those that were not planned to be sold at the time of the exhibition, but are presented at the exhibition, may cause some compl...
On the appointment of UNI-CERT to conduct an assessment of compliance with the requirements of the Technical Regulations of personal protective equipment No. 761
In accordance with Order No. 1153 of 06/18/2020 of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the Ukrainian Scientific Institute of Certification became the designated Body for Conformity Assessment to assess compliance with the Technical Regulations of Personal Protective Equipment, approved by the Cabinet of Ministers...
On March 22, 2020, Ukrainian Scientific Institute of Certification celebrated its 10th anniversary
This is a great opportunity to thank our staff for non-stop dedication and hard expert work we did together and continue to do, always keeping with our goals. Our successes and achievements had grown from collaboration and mutual support built by past and present generations of employees. We improve product quality, ensure compliance with requir...
A cycle of publications of our specialists in specialized media has begun
A new issue of a professional publication for pharmaceutical industry specialists PharmaTechExpo Journal (№1-2, 2020) has been released. Two articles of our experts have been published there. They open a series of publications in specialized media dedicated to technical regulation topics of a very wide range of medical devices. We hope that an info...
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...
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.
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...
Be attentive! Cases of certificate falsification became more frequent!
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