The 10th anniversary Ukrainian forum of medical device market operators was held


On May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience.

Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of UNI-CERT LLC, during the session “Technical regulation and conformity assessment of medical devices” made a report on the certification of medical devices during a pandemic, especially drawing the attention of the participants to the most important issues in such a situation, related to remote audits and the recognition of the results of conformity assessment carried out outside of Ukraine.

After the end of the session, a lively discussion took place with the participation of representatives of state, regulatory and supervisory authorities, in which possible practical solutions were discussed to overcome the difficulties of market participants associated with maintaining the validity of certificates during a pandemic and a simplified procedure for introducing medical devices to the Ukrainian market.

Other news


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

Read more

The 3rd Ukrainian Forum of Market Operators of Cosmetic Products and Disinfectants took place

Text is available only in Ukrainian

Read more

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

Read more