Events

25.08.2023

New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

The Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]

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14.07.2023

A contract on recognition of the results of the assessment of conformity with SGS Belgium NV (ID 1639)

We are pleased to inform you that the notified body SGS Belgium NV (ID 1639) 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 certification of their products in Ukraine. We have already accumulated sufficient […]

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13.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates

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01.02.2023

Register of persons responsible for the placing medical devices on the market has become operational in Ukraine

The Register of persons responsible for the placing medical devices on the market is displayed in public access on the official website of the State Service of Ukraine on Medicines and Drugs Control, providing the possibility of convenient search of information in the Register of Persons in accordance with the specified search parameters, at the […]

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09.01.2023

Public health: more time to certify medical devices to mitigate risks of shortages

On January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will […]

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29.08.2022

The 11th Ukrainian forum of medical device market operators was held

On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law. Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head […]

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