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 >>...
Interview of the UNI-SERT management for the Pharmacy Weekly
The Ukrainian Scientific Institute of Certification is rapidly expanding its ambitions: expanding the range of services, modernizing the laboratory and constantly finding new ways to increase the efficiency of its own activities. The largest Ukrainian medical publication Pharmacy Weekly became interested in the reasons for such changes. Management ...
The seminar will be held at the exhibition “PHARMATechExpo 2019” on September 18
September 18, 2019 10.30 - 13.00 | HALL №2 Seminar "Medical products in the range of pharmaceutical manufacturers. Conformity assessment of medical devices for in-vitro diagnostics"
Significant scope expansion
UNI-CERT LLC received a new Accreditation certificate №1O302 from 13.05.2019 and significantly expanded its Scope of accreditation. Presently, UNI-CERT is an accredited conformity assessment body for the following products: - medical devices - in vitro diagnostic medical devices - active implantable medical devices - large and small domestic ...
Impact of Law of Ukraine ‘On Ensuring the Functioning of the Ukrainian Language as the State Language’ on medical devices’ placing on the market and sales on the territory of Ukraine
On April 25, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” was published. The Law enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions. The Law states that the only state (official) language in Ukraine is the Ukraini...
A contract on recognition of the results of the assessment of conformity with CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409)
Dear colleagues! We are pleased to inform you that the notified body CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certi...
Conference ‘Market surveillance of medical devices in aesthetic medicine and dentistry’ was held on June 14, 2019
‘Premier Expo’ in conjunction with the Ukrainian Scientific Institute of Certification on June 14 at MIM Business School organized and conducted an educational event on topical issues of inspections by government market surveillance authorities of medical devices in aesthetic medicine and dentistry for managers of distributors and suppliers, regula...
Expansion of the scope of accreditation
In February 2019, UNI-CERT LLC passed a scheduled audit and expanded its scope of accreditation. In accordance with new the accreditation certificate No. 80103 of 11.05.2019 and the scope of accreditation, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards: ...