In connection with the cancellation of the appointment of UMCC for conformity assessment work, we inform you
The Ministry of Economic Development, Trade and Agriculture of Ukraine, by order of 21.09.2020 №1848-20, annulled the appointment of UMCC as a body for assessing the conformity of products to the requirements of the Technical Regulations for Medical Devices, Technical Regulations for Medical Devices for In Vitro Diagnostics and Technical regulations on active implantable medical devices.
The reason for cancellation of the appointment is the expiration of the certificate of accreditation of UMCC in accordance with the requirements of ISO / IEС 17065 in the relevant field.
UMTCC completes re-accreditation at NAAU. All necessary observations and audits have already been carried out. In the near future we expect to receive a certificate of accreditation in accordance with the requirements of ISO / IEС 17065 in the relevant field. It should be noted that the application was submitted in the fall of 2019, and the delay in obtaining a new accreditation certificate was caused by quarantine restrictions, due to which NAAU was not able to conduct an audit of UMCC for a long time.
After receiving the certificate of accreditation, the appointment of UMCC as a body for conformity assessment of products to the requirements of the mentioned Technical Regulations will be renewed, after which we will continue to provide conformity assessment services.
Please note that according to the current version of the Law of Ukraine "On Technical Regulations and Conformity Assessment" (Article 371) in case of reduction of the scope, suspension or revocation of the certificate of conformity, documents issued by the relevant designated authorities remain valid.
Thus, all certificates of conformity issued by UMCC are valid.
Please note that messages sent to our customers by dishonest competitors, in addition to the facts, may contain fakes. We work and you can contact us to find out any questions.
UMCC expects to receive the appointment in the near future and plans to continue to provide services to assess compliance with the requirements of the Technical Regulations, in particular - supervision and support of already issued certificates, as well as certification of new products.