In accordance with Article 16 of Law No. 04/L 190 on Medical Products and Devices (Official Gazette of the Republic of Kosovo /no.27/25 April 2014), Article 11, paragraph 1, subparagraph 1.5 of Law No.08/1-117 on the Government of the Republic of Kosovo, Article 9 paragraph 2 of the Government Regulation No.17/2024 (Official Gazette dated 21.06.2024)