Ukrainian Scientific Institute of Certification

Selfdeclaration

24/07/2018

Procedure of self-declaration applies to following medical devices:

For devices listed above, it is not required to submit documents and to pass examinations in any conformity assessment body, except how to inform the State Service of Ukraine on Medicines and Drug control accordingly. In order to comply with the requirements of the Technical Regulations for such medical devices, it is necessary:

  • Appoint an authorized representative of the manufacturer in Ukraine, perform all related legal formalities;
  • Generate technical documentation (hereinafter – the Technical File), in accordance with the requirements of the relevant Regulations and procedures; perform the necessary translations;
  • Draw up a Declaration of Conformity to the requirements of the Technical Regulations;
  • Submit information about the location of the manufacturer/ authorized representative in Ukraine, a list and description of the devices to the State Administration of Ukraine on Medical Devices;
  • Affix the symbol of conformity on the label of the medical device, check compliance of the requirements of the Technical Regulations and current legislation for labeling and instruction for use (user’s manual).

For these devices, there is a declaration of conformity, a document that confirms their compliance with the requirements of the Technical Regulation and, therefore, is the basis for their placement on the Ukrainian market. Particular attention when declaring compliance with the Technical Regulations should be paid to the fulfillment of all the requirements and formalities, including those entrusted to the authorized representative, as medical devices become the subject of the market supervision from the moment of their admission into the customs territory of Ukraine.

In order to reduce potential problems that may arise during customs control, or when conducting market surveillance in relation to such products, the Ukrainian Scientific Institute of Certification offers the following services:

  • confirmation of the belonging of products to medical devices;
  • confirmation of the correct classification of the product, in accordance with the requirements of technical regulations;
  • assessment of the completeness of the declaration of conformity;
  • assessment of labeling, instructions for use of a medical device to the technical regulations requirements;
  • assessment of the compliance of the medical device Technical File with the requirements of technical regulations and the issuance of a corresponding certificate.

In order to receive individual information, you can contact us by phone at +38 (044) 227-41-46 or write to office@uni-cert.ua

Return to CONFORMITY ASSESSMENT