Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian

Conformity assessment of personal protective equipment in accordance with the new Technical Regulations No. 771

Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]