Analysis of manufacturer or supplier documents

• we check technical descriptions, passports, instructions, certificates of conformity;
• we determine which document is required: a declaration of conformity with Technical Regulations, a type examination certificate, or a conclusion of sanitary and epidemiological examination.

Certification of new X-ray machines

• support of the conformity assessment procedure in an accredited body;
• organisation of laboratory tests (if necessary);
• issuance of a certificate of conformity or declaration taking into account the requirements of the Technical Regulations for medical devices or industrial equipment.

Certification of second-hand X-ray equipment

To import or transfer second-hand X-ray equipment into use, it is necessary to:
• confirm technical serviceability and safety through independent examination or conformity assessment;
• obtain a technical condition report prepared by an authorised specialist;
• prepare a set of documents for import and further operation in Ukraine;
• if necessary, undergo recertification with updating of technical documentation in accordance with Ukrainian standards.

Preparation for customs clearance

• Determination of the UKTZED code, preparation of document translations;
• Support in obtaining permits from the SNRIU (if the equipment is a source of ionising radiation);
• Consultations on optimising customs payments and import conditions.

Turnkey customs clearance

• broker representation, preparation of declarations;
• support during customs control;
• control of deadlines and absence of delays at customs

Commissioning or transfer for use

• Registration of medical devices with the Ministry of Health (for medical X-ray equipment);
• Preparation of a set of documents for further licensing of operation in Ukraine.