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:
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:
In order to receive individual information, you can contact us by phone at +38 (044) 227-41-46 or write to email@example.com
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