It is reported that during an unscheduled inspection in Likomed LLC, incorrect information was found that was entered in the declaration of conformity of the product. In particular, the document indicated that the medical device belongs to safety class I and does not require the involvement of a conformity assessment body to conduct a conformity assessment procedure and is non-sterile.
The State Service indicated that this medical device belongs to safety class IIA and is sterile, which requires the involvement of a conformity assessment body.
In addition, other violations of the Technical Regulations were identified.
As we reported, the government of Norway will allocate almost $4 million for the financing of the cooperation with Ukraine in health care